Regulatory Program Manager Resume Samples

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M Funk

Myriam

Funk

66497 Sage Glens

Dallas

+1 (555) 361 0662

66497 Sage Glens

Dallas

Phone

p +1 (555) 361 0662

Experience Experience

Chicago, IL

Regulatory Program Manager

Chicago, IL

Zulauf Group

Chicago, IL

Regulatory Program Manager

This is a great opportunity for a programme manager to join a high-performing and successful development group within a leading, global Investment Bank
Provide leadership and program management for projects as directed by manager
Establish and provide tactical alignment across PCMS on regulatory aspects of
Liaise with Project Managers, Development Leads and Business Analysts to plan, track and deliver large regulatory programmes
Working on a portfolio of projects with critical deadlines and as part of a global team
Manage Governance and stakeholder reporting to broad range of senior stakeholders across the organisation
Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws, regulations and standards including ISO 14971, IEC 60601-1 and related particular standards

Los Angeles, CA

Regulatory Operational Excellence Program Manager

Los Angeles, CA

Little and Sons

Los Angeles, CA

Regulatory Operational Excellence Program Manager

The primary responsibility of this role, as Regulatory Affairs Operational Excellence Project Manager is: To ensure the development and implementation of strategic operational objectives for Radiology Regulatory Affairs that drive the creation and maintenance of an aligned “best in class” Regulatory Affairs Organization
To help ensure the development and implementation of various strategic operational objectives for Radiology Regulatory Affairs that drive the creation and maintenance of an aligned “best in class” Global Regulatory Affairs Organization
To ensure that the Regulatory Affairs processes for medical devices across Bayer Medical Care are harmonized, standardized, and optimally implemented
To ensure the definition, development, and implementation of best in class Regulatory Affairs processes, applied technologies, and regulatory quality standards; with a focus on medical devices and combination products
To be responsible for creating GRA MC action teams to support BHC and BMC continuous process improvement initiatives
To be responsible for leading cross-functional teams
To ensure the continuous assessment of process workflows to maximize efficiencies

present

Houston, TX

Global Regulatory Reporting Controls Oversight Transaction Review Program Manager

Houston, TX

Schroeder, Hudson and McKenzie

present

Houston, TX

Global Regulatory Reporting Controls Oversight Transaction Review Program Manager

present

Responsibilities of Transaction Review Project Manager include
Project management and status reporting
Perform US Team and FAKC team coordination
Oversee the end-to-end data quality review process, including scope development, sampling, transaction testing, and communication of observations for assigned area of banking product focus (Wholesale Banking, Mortgage Lending, Consumer Lending, Trading Products)
Coordinate with central CCAR Project Management Office to ensure accurate reporting of progress, status, and risks
Oversee the progress, status, and risks across all activities for end-to-end components in the testing program (prioritization, sampling, testing, observations / issues)
Coordinate with Centralized Regulatory Reporting (CRR), Front Line Units (FLUs), and data providers to verify the sampling approach

Education Education

Bachelor’s Degree in Healthcare Related Field

University of Oregon

Bachelor’s Degree in Healthcare Related Field

Skills Skills

Philips PCMS experience highly desired
Proficient computer skills in Microsoft Office
Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws, regulations and standards including ISO 14971, IEC 60601-1 and related particular standards
Ability to manage and influence senior stakeholders
Ability to work with disparate development teams using both waterfall and agile methodologies
Strong background in Design Controls
LI-Recruiter
Experience in supporting international registrations and/or clinical investigations
LI-Priority
Understand LEAN concepts, methodologies and deployment

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Global Regulatory Program Manager Resume Examples & Samples

Bachelor's Degree in the Sciences
Knowledge of FDA regulations
Able to work effectively in a matrix team environment
5+ years of experience in regulatory affairs
Pharm D

Regulatory Program Manager Resume Examples & Samples

The scope of the team is global and wide ranging, which reflects the regulatory portfolio of a large global business, and hence the depth and knowledge of the regulatory landscape, as well as, understanding of the impact to an asset management firm is critical
Focus on regulatory management and implementation. Your knowledge and subject expertise will be used to assist the business with implementation of many regulatory initiatives
This challenging role requires working very independently with a very pragmatic and hands-on work approach
Working on a portfolio of projects with critical deadlines and as part of a global team
Engagement with internal stakeholders and external industry regulatory experts
Proven track record of management complex projects from impact assessment through to implementation, including planning, as well as, execution
Strong communication skills are required, complimented by a convincing and persistent personality in order to be successful in this role
You will be a highly organised, proactive and credible professional that is able to work efficiently and effectively under project deadlines
University degree and/or equivalent work experience

Regulatory Interaction & Examination Senior Program Manager Resume Examples & Samples

Support the definition and communication strategies for regulatory exam management in order to meet Citi’s legal, regulatory and compliance requirements
Support the regulatory examination process as a lead contact/central point of communication with regulators for examinations and requests – schedule, objectives, etc. – and provide status updates to O&T Senior Management on periodic basis
Drive the collection, review and management of deliverables required for successful completion of Regulatory examinations and ongoing requests
Coordinate, develop and review regulatory examinations draft responses
Support the quality assurance process of evidentiary materials in support of issue closure
Support the coordination of O&T level communications and engagement with Audit Workgroup
7 - 10 years experience working in operations and technology risk and / or control functions within a financial services organization
3- 5 years experience working with external regulators within a financial services organization
Effective leadership skills
Strong written and oral communications skills, including presentation skills
Able to communicate effectively at all levels of the organization
Individual should be analytical, flexible, team-oriented, have good interpersonal and follow up skills with strong attention to detail and ability to multi-task
4 year College Degree, or equivalent experience

Regulatory Interaction & Examination Senior Program Manager Resume Examples & Samples

Support the regulatory examination process as a lead or support contact/central point of communication with regulators for examinations and requests – schedule, objectives, etc. – and provide status updates to IS Senior Management on periodic basis
Collect, review and manage deliverables required for successful completion of Regulatory examinations and requests
Analyze regulatory requirements and help define and/or validate the controls that address the requirements
Utilize strong analytical skills to evaluate controls, identify control issues, review project plans and corrective actions to identify missing milestones and tasks
7 – 10 years experience working in technology risk and / or control functions within a financial services organization
Technical expertise/acumen of distributed, network and mainframe platforms/environments
Experience in managing global or cross-business projects in a matrix organizational structure is required
Demonstrated leadership and adaptability when facing unique challenges of a dynamic organization
Strong interpersonal skills, including the ability to partner with others and deal effectively with multiple projects and changing priorities
Excellent influencing and negotiation skills and ability to work effectively with all levels of the organization as well as geographically disbursed teams
Able to take ideas from concept to execution
Proven ability to work independently in a fast paced multi-tasking environment
Technical proficiencies in MS Word, Excel, PowerPoint and Visio

Regulatory Program Manager Resume Examples & Samples

Product Control RPL central representative and primary contact point in regulatory related matters
Oversee and direct changes to the methodology and logic utilized in supporting Regulatory compliance
Monitor changes in the regulatory environment and make appropriate plans to ensure Product Control’s compliance
Identify and coordinate the execution of process standardization initiatives across Product Control RPL and oversee ongoing compliance thereon
Develop and present material to various stakeholders to enhance regulatory comprehension and help drive better business decisions
8-10 years experience in financial services, preferably in Product Control, having undertaken Regulatory program related roles within complex cash & derivatives areas
Product Control / Risk experience, ideally within cash and derivatives (OTC & Listed)
Experience in regulatory driven programs, Basel III, IHC and Volcker preferred
Excellent Presentation skills, proven proficiency in PowerPoint
Proven track record of program management and delivery
Understanding of the P&L and balance sheet process in a trading environment

Privacy & Regulatory Program Manager Resume Examples & Samples

Help to coordinate Facebook's global privacy program framework for the legal department
Work on projects related to ongoing compliance with data protection and privacy laws, and related requirements, including in particular ongoing maintenance and improvement of our internal privacy program
Document Facebook's global legal obligations, including commitments to the Irish Data Protection Office and the US Federal Trade Commission
Coordinate regular and comprehensive audits of our systems and procedures, which are then audited by independent accounting firms
Assist in the development and deployment of trainings that highlight rules and regulations that companies must adhere to successfully meet legal requirements
B.A. or B.S. degree or equivalent with 8 or more years of experience in Privacy, preferably within a legal environment, consulting firm or prior in-house experience with internet or technology companies
Candidates must be very flexible and willing to work on projects in other areas
Demonstrated ability to work in fast-paced environment and under tight deadlines
Demonstrated ability to advance large, complex projects as a project manager
Talent for thinking creatively in confronting new issues and pursuing novel approaches to old problems
Strong knowledge of and interest in emerging technologies and devices and of Facebook products and platform if preferred
Privacy certification (e.g. CIPP or CIPM or similar) is preferred
Excellent academic credentials

Program Manager, Quality & Regulatory Build Resume Examples & Samples

Experience with build and architecture of Electronic Health Record (EHR) in care delivery, preferably Epic
Minimum of 3 years of project management experience and project oversight, preferably with one or more EHR
Demonstrated ability to identify, design and implement process improvement, as evidenced by achieved and
Knowledge of primary and specialty care and large-scale deployment techniques

Privacy & Legal / Regulatory Program Manager Resume Examples & Samples

Partner with stakeholders throughout CCB including Digital’s Control Partners - Legal, Compliance, Risk, and Controls for Legal/Regulatory Procedures, Action Plans, RCSA and other Privacy tasks for sustainability
Assist in the establishment and implementation of effective Privacy, Data Management, Information Owner practices within Digital including coordination with the Global Privacy Office
Facilitate and track Digital Privacy and Legal/Regulatory Procedure reviews
Record Retention - recertification of non SEAL, CC validation and impact assessments if Global changes mandated (i.e. legal requirement to change retention)
Digital Retention Purge – coordinate overall Privacy office reviews and actions based on purge processes (i.e. if profile rules change)
Facilitate and gather Audit evidence as needed
Be available to support the respective Privacy and Legal/Regulatory Compliance Lead and participate in workgroups, strategic projects or targeted reviews that require business engagement
Drive the implementation of LOB Privacy and Legal/Regulatory procedures and ensure that such procedures are maintained, accurately and comply with applicable policies and requirements
Assist the business with the design and execution of controls to address privacy business requirements and mitigate privacy risks
Assess the impact of Legal and Regulatory changes (Privacy, UDAAP, etc) on the business & technology operations, processes or procedures, including modifications needed. Provide transparency to Compliance, Controls, Risk, Legal Leads into the LOB preparedness for complying with regulatory change
Assist and facilitate the business with preparing for Legal/Regulatory related exams, compliance tests and internal audits and notify and engage Compliance, Control Leads during such reviews
Manage assigned Legal/Regulatory issues in FORCE or other system of record; escalate risks to management and to Control Partners. Where appropriate take ownership for actions in FORCE with respect to areas such as execution of controls
Work within the business to ensure that privacy incidents are reported timely and accurately to the Privacy Incident Response Lead, in accordance with policy; assist LOB in determining necessary client notifications as appropriate
Manage the local college internship program which involves working with local colleges in the interviewing, hiring, onboarding and coaching of interns
Excellent oral, written, and presentation communication skills
8+ years experience in related role
BS/BA in Business, Computer Science or related field
Must be extremely organized, detail-oriented and capable of self-managing and multi-tasking in a fast-paced, demanding environment
Self-starter with excellent time management and problem-solving skills
Exceptional interpersonal skills with proven experience in relationship building, influencing and partnering
Ability to work independently and in groups including global matrix managed organizations
A solid understanding and comfort level with MS Office including, Excel, Word, PowerPoint, Project and Share Point is required
Experience in implementing legal and/or compliance requirements into business practices (processes & procedures) and conducting privacy, operational and/or technology risk assessments
Understanding of processes and information flows for business and operational units that manage customer, employee data and other confidential information
Relevant experience working with support functions such as operations, controls, marketing, preference collection, information management, information technology, and third party management. Privacy operations experience a plus

Regulatory Operational Excellence Program Manager Resume Examples & Samples

The primary responsibility of this role, as Regulatory Affairs Operational Excellence Project Manager is: To ensure the development and implementation of strategic operational objectives for Radiology Regulatory Affairs that drive the creation and maintenance of an aligned “best in class” Regulatory Affairs Organization
To help ensure the development and implementation of various strategic operational objectives for Radiology Regulatory Affairs that drive the creation and maintenance of an aligned “best in class” Global Regulatory Affairs Organization
To ensure that the Regulatory Affairs processes for medical devices across Bayer Medical Care are harmonized, standardized, and optimally implemented
To ensure the definition, development, and implementation of best in class Regulatory Affairs processes, applied technologies, and regulatory quality standards; with a focus on medical devices and combination products
To be responsible for creating GRA MC action teams to support BHC and BMC continuous process improvement initiatives
To be responsible for leading cross-functional teams
To ensure the continuous assessment of process workflows to maximize efficiencies
To ensure the development of effective regulatory processes that support competitive labeling
To ensure the creation and implementation of global regulatory processes that render comprehensive regulatory plans, assessments, and strategies that are based on the effective interpretation of current global regulatory requirements
To create processes that effectively monitor global regulatory environments and anticipate changes in regulations, guidelines, etc. that may affect the clearance/approval of new devices & drugs or current marketed devices & drugs
To foster team spirit and cooperation within GRA, across the different functions of MC Innovation/CMO, and other BHC divisional GRA organizations
To ensure the development and implementation of strategic operational objectives for Global Regulatory Affairs Medical Care that drive the creation and maintenance of an aligned “best in class” Regulatory Affairs Organization
To ensure that the Regulatory Affairs processes for medical devices across Bayer HealthCare are harmonized, standardized, and optimally implemented
To ensure the definition, development, and implementation of “best in class” Regulatory Affairs processes, applied technologies, and regulatory quality standards; with a focus on medical devices and combination products
To help create and lead cross-functional teams to support BHC continuous process improvement initiatives
To continuously assess process workflows and assist in the development of optimization tools to maximize efficiencies where possible
Bachelor's degree from a four-year college or university required
Minimum of 5-9 years of experience in the healthcare industry including Regulatory Affairs
Strong domain knowledge of global medical devices
Strong domain knowledge of global medical device requirements
Strong domain knowledge of global medical device quality standards and compliance requirements
Strong domain knowledge of design controls for medical devices
Strong understanding of the working of global regulatory agencies
Strong analytical, problem solving, and strategic skills with good business acumen
Strong networking abilities
Used to interacting with and leading international and multicultural teams
Possess an understanding of marketing of medical devices
Project team environment experience
Proven track record in people/team building skills
Must be motivated to work independently as well as with cross-functional teams
Skill and determination to reach successful outcomes in negotiations with both inside team clients and outside parties e.g., Regulatory agencies
Self-starter with a proactive and energetic attitude
Solid communication skills in English and ability to communicate in regional language is also desired

Program Manager, Commercial Regulatory Resume Examples & Samples

Technical and Business Expertise – Applies emerging knowledge and trends in one’s area of expertise to improve results. Builds strong relationships with key customers. Contributes expertise to help colleagues within and beyond his or her area
Teamwork and Collaboration – Addresses and resolves conflict by creating an atmosphere of openness and trust. Establishes strong collaborative relationships. Inspires others to do their best work by offering support and encouragement
Achieving Results- Is goal-directed, persistent, driven to achieve objectives. Holds self accountable for meeting commitments. Recognizes the contributions of teammates and peers

Regulatory Intelligence Program Manager Resume Examples & Samples

Maintain existing EHS policies, processes, and guidelines. Develop new EHS policies, processes, and guidelines as required by regulatory changes and new business growth
Manage the EHS regulatory contacts process, including tracking, investigating and responding to contacts
Monitor emerging EHS regulations or interpretations and determine any that may have impact on the business. Communicate, partner and educate with necessary
Analyze EHS regulatory contacts to discover trends to justify the allocation of appropriate resources or program modifications to areas where risk is highest
Possess a detailed understanding of applicable legal requirements (i.e.: Codes, Standards, and Administrative Policies) and provide technical expertise, regulatory knowledge, and Amazon EHS policies
Provide program technical and administrative support in areas such as design-in-safety, risk assessment, job safety analysis, investigation and resolution, development and programming of EHS systems, and integrating EHS practices into operations processes
Provide technical capability to the EHS and engineering activities as they develop processes and procedures
Assist in the development of related processes and/or the integration of EHS elements into current processes
Provide ‘single-point of contact’ to the EHS team for understanding existing EHS regulations and regulatory activity (compliance of new technologies with applicable codes and standards)
Function as technical resource for FC and regional EHS staff
Serve as technical resource to the engineering team
Develop onboarding process and training materials designed specifically for EHS team members
Responsible for management and benchmarking best practices internal & external to North America
Through Six Sigma/Lean methodologies, partner with Operations and Engineering in reducing risks and injuries
Support the generation of the annual operating plans (OP1&2), Whistle Stops, Peak Plans, etc. and standardize tools used across NAFCs
A completed Bachelor’s Degree in industrial safety or other engineering discipline from an accredited university or 2+ years Amazon experience
3+ years’ experience serving as an EHS technical resource or program manager
Experience analyzing and interpreting data
Experience solving large scale, cross-functional EHS problems in a manufacturing of distribution center environment
Strong attention to details and ability to multi-task multiple urgent issues at once
Should possess or be working towards recognized professional certification
Excellent written and verbal communication skills, including comfort interfacing with the FCs safety and leadership teams
Experience in a fast paced, changing/growing organization is a plus
Experience demonstrating a high level of interpersonal skills to work effectively with others
Legal background (paralegal or otherwise)

Global Consumer Bank Cborc Tax Regulatory Program Manager Resume Examples & Samples

Leadership and oversight over the day to day program management of 4 key project workstreams: Foreign Account Tax Compliance Act (FATCA), The Common Reporting Standard (CRS), 871(m) and Tax Transparency
Ownership of all senior management materials including senior management project updates, senior management proposals on approach, etc
Ownership of the Tax Regulatory Operating Committee and Senior Management Update meeting agenda, materials and organization
Drive process and procedure review across all countries to develop standardization and best practices in meeting compliance requirements
Lead efforts to escalate and develop mitigation/remediation plans against issues and/or risks identified across any of the projects
Coordination of requests from senior management on an ad-hoc basis
Maintain effective communications to all stakeholders, ensuring team interaction model is transparent and effective
Oversight of new project plan creation or updates to project plans, distribution and review for all GCB countries. This occurs at least every 6 months, and sometimes quarterly based on program needs
Defines strategy and plan for program communications and oversees the coordination of any global level communications that are distributed to all GCB employees
Strong knowledge and proven adherence to the Citi Project Management Policy (CPMC)
Bachelor's Degree required; MBA/MS preferred
Strong interpersonal, influencing and written/verbal communication skills
Forward thinker with independence of thought
Proven capability to adapt in a face passed, evolving work environment

Product Safety & Regulatory Program Manager Resume Examples & Samples

The Product Safety and Regulatory (PS & Reg) Leapfrog program manager ensures that the “Leapfrog” program (~8 projects) is managed in a coordinated way
The program manager is accountable for program delivery through design phase until successful implementation in this multi-year transformation up until end of 2019
Own the Leapfrog master plan for all related initiatives and ensure that it remains cohesive and in line with overall vision and blueprint for PS & Reg
Provide transparency and clarity on program plans and progress to enable informed decision making by senior stakeholders
This role will be accountable for communicating escalated risks for review & mitigation, also for reporting, in agreed upon format for consolidation & review by the relevant governance and steering committees
This role, will coordinate closely with the Program senior responsible owner (SRO) and business change managers (BCM) & global business process owners (GBPO) to ensure that all related projects globally and within the region will be delivered
Ensure that Syngenta’s program and project management methodologies (MSP, BCM) are followed, including proposed stage gate advancement approach, status reporting, issues and risk management
Deliver transparency regarding cross project / program interdependencies, with emphasis on understanding impact of projects on the regional population, working with respective project teams to improve coordination and mitigate related risk
This role will also liaise as required with others to engage with stakeholders in all regions and partnering functions and leadership teams to successfully deliver the leapfrog program
People leadership of directly 9 and indirectly 3 ( Manage 6 Project managers and PMO team of 3 as well as indirectly the change and comms team ~3FTE))
Manage external provider who deliver services to the program (consultancies, implementation partner, IS vendors,…)
Collaborating with the various project managers and business owners to ensure that the timing and content of planned program deliverables are feasible
Undertaking qualitative reviews as required on mandatory project support documents
Challenging & validating that required program governance framework is adhered to
Providing guidance and support to project teams, on any and all related project issues, including training on proposed project governance & related methodologies
Day-to-day management of the program from ‘design’ to ‘closure&#8217
Planning and designing the program and proactively monitoring its overall progress, reporting the progress at regular intervals
Managing and resolving risks and issues
Ensuring key documents are created and updated as necessary, such as the Blueprint and Benefits Map And Benefit Profiles
Defining the program governance framework
Monitoring the program budget and the expenditures and costs against benefits that are realized as the program progresses
Collaborating with the business leads to ensure that the timing and content of planned program deliverables are feasible in the relevant business areas
Managing the communications with stakeholders by initiating activities and interventions as needed
Engaging up to SEC level with funding submissions and progress presentations

Global Regulatory Relations Group Central Team Operations & Program Manager Resume Examples & Samples

Provide support to the Global Head of GRRG in continuing to build out and centralize the GRRG operational framework
Coordinate organizational and administrative matters, such as annual budget, organizational charts, and GRRG Business Continuity Planning
Communicate and coordinate regularly with regional Regulatory Relations Group (RRG) teams, including regarding status of exams, findings and reporting
Review RRG reporting and external regulatory and industry news to identify key supervisory developments and trends; synthesize into global reports for the Firm’s senior executives and stakeholders
Assist in producing and preparing agendas and materials for management meetings between the Global Head and RRG Heads or other Firm staff and regulatory or other external meetings, as appropriate
Develop and prepare reporting and metrics from the OpenPages assessment management tool (GRAMS) for the Global Head and Central Team
Manage special initiatives and ad hoc projects, as appropriate
Assist with development of the GRRG Annual/Strategic Plan and tracking of progress to plan
Coordinate and produce global training efforts
Contribute to annual or periodic updates to policies and procedures
Maintain the GRRG LCD Portal InfoPage
Participate in Divisional or Firm-wide initiatives/projects on behalf of GRRG, as appropriate (e.g., Firm Recovery/Resolution Communications Plan; Annual Operational Mapping Exercise)
4+ years of in-house compliance or legal, law firm or government regulatory experience
Highly motivated self-starter able to work independently while collaborating and coordinating as part of a global program
Strong interpersonal skills and the ability to work collaboratively with people at all levels of the organization
Keen attention to detail and desire to take final ownership of content in deliverables
Ability to quickly grasp key concepts, multitask, flexible, able to manage quick demands, change of priorities
Strong analytical and assessment skills
Strong time management skills and project management skills
Proficient office productivity tools skills (Word, Excel, PowerPoint, Visio, SharePoint

Program Manager, Senior, Quality & Regulatory Resume Examples & Samples

A Bachelor’s degree or your country’s equivalent
Knowledge and experience in ERP (SAP, Oracle, or similar), Quality Management Software (TrackWise, TeamTrack, or similar), and/or Data Visualization Tools (QlikView, Tableau, Business Objects, or similar)
Evidence of strong project management skills
Fluency in written/spoken English
An analytical and solution-oriented mindset, with the ability to set goals and motivate a multi-functional, remote team to achieve them

Program Manager Quality & Regulatory Resume Examples & Samples

12+ years of related experience in a medical device regulations industry
5+ years of management experience and played a quality site leader role in a matrixed organization
Demonstrated knowledge & expertise on subjects mentioned below but not limited to
SO Standards (i.e., 13485, 14971, 14001)
US, EU & International Medical Device Regulations (i.e., 21 CFR 820, MDD)
Medical Device Design Control Requirements
Lead / Internal Auditor Training
Excellent Communication
Excellent QA/Regulatory Writing Skills in English
Proficient in Microsoft and other organizational tools
Ability to effectively interact with various business departments & resolve QA compliance/technical issues/conflicts

Regulatory Program Manager Resume Examples & Samples

Liaise with Project Managers, Development Leads and Business Analysts to plan, track and deliver large regulatory programmes
Manage Governance and stakeholder reporting to broad range of senior stakeholders across the organisation
Drive issues to resolution, not just track and report actions
Track record as a Project Manager within the Financial Services/Investment Banking industry
Experience in delivering Regulatory change projects from an end-to-end perspective as a project manager
Experience of managing QA and UAT testing across multiple applications/teams
Ability to manage and influence senior stakeholders
Ability to work with disparate development teams using both waterfall and agile methodologies
Good degree in IT (but will consider a strong Mathematics, Engineering, Arts or other Science degree, or equivalent Commercial experience)

Regulatory Labeling Program Manager Resume Examples & Samples

5+ years of regulatory affairs related experience with a Bachelor’s degree
3+ years of regulatory affairs related experience with a Master’s degree
2+ years of experience managing projects or programs under design controls including managing schedules, milestones, deliverables, and resources
1+ years of experience managing complex projects or programs, especially electronic products, labeling, medical devices or pharmaceuticals
1+ years of experience leading projects to completion
Excellent people and communication skills (verbal and written)
Technical Writing experience in a regulated environment
Experience writing in or developing XML publishing systems (2+ years)
Experience interacting with a broad range of functional groups and individuals at various levels of the organization
Experience managing multiple projects successfully
Experience using electronic tools for managing projects, routing reviews and approvals, allocating resources, etc
2+ years of experience in cross-functional, cross-geography project management
2+ years of experience in a labeling creation environment
Experience working with cross-geography projects and teams
Experience working on projects requiring localization/translation
Experience in usability or human factors
Experience working with content management systems

Global Regulatory Reporting Controls Oversight Transaction Review Program Manager Resume Examples & Samples

Bachelor's Degree (Accounting or Finance Strongly Preferred)
7+ years of experience in regulatory reporting, including preparing, auditing, examining, or conducting transaction-level data quality reviews of the regulatory reports (e.g. FR Y-9C, FR Y-14Q/M, 14A, FFIEC 101)
Strong technical knowledge of banking products (Wholesale Banking, Mortgage Lending, Consumer Lending, Trading Products) and U.S. GAAP (CPA, CFA, or equivalent certifications preferred)
7+ years of relevant internal control governance, audit testing and leadership experience, specifically in areas of accounting, testing, SOX internal control, and finance in a large, fast-paced, results-oriented company with a demonstrated history of success
Strong relationship management skills to navigate the complexities of aligning stakeholders, building consensus and resolving conflicts in a large, distributed organization; proven ability to influence peers/stakeholders and senior leaders across various lines of business
Proven ability to manage multiple and often competing priorities in a global environment; Ability to drive strategic initiatives with a track record of successful change and making difficult decisions
Ability to decompose complex issues and drive timely decisions, knowing when to engage others for additional input, and when to act independently; Proven ability to manage and develop team members
Strong executor that is able to lead across organizational lines and drive progress on priorities and issues
Ability to communicate complex ideas in a clear and concise manner, shaping the opinions and actions of key stakeholders and gaining their trust.

Accreditation & Regulatory Program Manager Resume Examples & Samples

Knowledge of regulatory requirements (TJC and CMS)
Knowledge of the accreditation process
Knowledge of survey preparation and required follow-up activities
Skill in written and oral communications
Skill in conducting mock regulatory surveys using the tracer methodology
Ability to interpret, prepare, and present reports to management in both written and oral formats
Ability to make presentations, design and provide training/education to staff and management

Regulatory Program Manager Resume Examples & Samples

Bachelor’s degree (Master’s preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry
RAPs RAC strongly preferred. ASQ certifications also desirable
Minimum of eight years of experience in the medical device industry (EU MDD, Health Canada, China, US FDA class II and/or class III, etc.)
Must have personal experience with successful preparation and submission of 510(k) and/or PMA submissions
Strong background in Design Controls
Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws, regulations and standards including ISO 14971, IEC 60601-1 and related particular standards
Experience in supporting international registrations and/or clinical investigations
Proficient computer skills in Microsoft Office
Understand LEAN concepts, methodologies and deployment
Philips PCMS experience highly desired
May require 10% travel annually with possibly some international

Compliance / Regulatory Program Manager Resume Examples & Samples

Identifies, reads, analyzes, and interprets statutes and regulations related to Medicare, Medicaid, other third party payor billing requirements, HIPAA, HITECH, or other privacy and security requirements. Assesses impact on Intermountain operations and identifies operational and clinical areas affected. Translates complex legal text into understandable language and identify action steps for individuals and departments to act upon across corporation
Provides guidance to affected individuals and departments developing action plans to implement new statutory and regulatory mandates, and ensures the completion, sufficiency, and sustainability of those plans. Serves as facilitator and point person to coordinate efforts among affected business segments within and external to Intermountain as new billing practices are implemented as needed. Tracks responses of operational areas implementing new billing requirements
Manages multiple projects relating to area of focus. Leads teams, presents information, recommends processes, implement processes, etc
Develops new and supports existing processes to identify and address compliance issues: Staffs Compliance Hotline (rotating schedule). Supports and/or conducts investigation of compliance issues. Assists in developing quality improvement plans
Supports Work Group Compliance Specialists and their teams: Research of regulatory information, as needed. Assists with policy and procedure development, development of Work Group Compliance Team compliance-related training programs, and prioritizing compliance tasks based on risk assessments. Attends Work Group Compliance Team meetings as needed. Risk-assess issues related to that Work Group specialty. Assists Work Group in establishing compliance-monitoring methods. Provides Work Group with compliance education applicable to operational area

Regulatory Affairs Program Manager Resume Examples & Samples

BS/BA in Engineering, Sciences, or similar related field
5+ years of project management experience in medical device/pharma industry with BS/BA
3+ years of project management experience in medical device/pharma industry with advanced degree
Quality System experience in a regulated industry (medical devices, pharma)
US medical product regulations (medical devices or pharma)
European Union medical product directives (medical devices or pharma)
Demonstrated competencies and ability to apply independently: Self-Management, Goal Achievement, Personal Accountability, Planning & Organizing, Resiliency, Flexibility, Teamwork, Leadership, Interpersonal Skills, Diplomacy & Tact, Customer Focus, Problem Solving Ability, Conceptual Thinking, Persuasion, Decision Making, Creativity, Verbal & Written Communication
Knowledgeable in worldwide regulatory requirements (e.g. FDA - QSR, ISO 13485, MDD, PAL, etc.)
Project Management Professional (PMP) Certification Master’s Degree in Engineering, Sciences or similar related field
Management of cross functional projects
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Senior Regulatory Labeling Program Manager Resume Examples & Samples

7+years of related experience with a Bachelor’s
5+ years of related experience with a Master’s
Minimum of 5 years of experience leading complex projects or teams

Program Manager of Regulatory Compliance Resume Examples & Samples

Bachelor’s degree in healthcare related field
Certified Professional in Healthcare Quality (CPHQ), Healthcare Accreditation Certified Professional (HACP), or Joint Commission Certified Professional (CJCP) required, or obtained within 12 months of hire
Current, non-encumbered health related licensure/certification (e.g. nursing, pharmacy, radiology, respiratory therapy, etc…)
Clinical acute care experience
2 years of progressive management experience
Experience in designing, implementing, and leading clinical outcome improvement programs
Previous experience with Joint Commission survey coordination at facility level
Excellent oral and written communication skills,
Master’s degree in health care related field

Regulatory & Standards Program Manager Resume Examples & Samples

Understanding of a broad range of global environmental regulations on restricted substances, energy efficiency, eco-design, and labeling
Understanding of existing multi-attribute environmental and sustainability standards on electronic products, such as EPEAT, IEEE 1680 and ULE 110
Knowledge of EPEAT policies and processes, as well as experience with product verification processes
Thrives in environments where attention to detail is required
Comfortable driving outcomes that require influence without control
Comfortable distilling information into crisp and concise messaging

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