Regulatory Program Manager Job Description
Regulatory program manager
provides subject matter advisor support to clients related to the Medical Device Directive (MDD) - Directive 93/42/EEC and the draft EU MDR Law (European Medical Device Regulation).
Regulatory Program Manager Duties & Responsibilities
To write an effective regulatory program manager job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory program manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Interface with other CS regulatory functions, such as Legal, Compliance, Risk, and Public Policy to determine applicability of regulations on AM
May prepare documentation and reports after interpretation of federal, state, and/or international regulations for submission to other units of the company, customers, governmental regulatory agencies
Partnership with EMEA CEO and EMEA COOs to ensure effective roll out and implementation of the program
Development of solutions to address regulatory issues, validation with the steering committee and oversight of effective implementation
Management of the local EMEA team in London and Geneva
Responsible for all Programme reporting regionally
Work with regulatory consultants/advisors for global strategic input and challenge
Develop and implement regulatory readiness with other line functions
Represent sub-teams as required
Determine requirements and sets objectives for Health Authority (HA) interactions with representative
Regulatory Program Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Program Manager
List any licenses or certifications required by the position: PMP, US, CE, ASQ, PMI, GMP, SEM, MDR, EU, CPA
Education for Regulatory Program Manager
Typically a job would require a certain level of education.
Employers hiring for the regulatory program manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Business, Engineering, Healthcare, Education, Management, Technical, English, Project Management, Communication
Skills for Regulatory Program Manager
Desired skills for regulatory program manager include:
FDA law
Medical device regulations
MDD
Regulations
Guidelines and regulatory requirements
IEC 60601-1 and related particular standards
Global laws
Global regulations
Nature and impact that the transition from the Medical Device Directive will have on Manufacturers and Notified Bodies
Desired experience for regulatory program manager includes:
Facilitate preparation and finalization of briefing books and contributes to preparation of summary documents
Develop and implement plans for timely response to requests and coordinates responses
Lead rehearsals for HA meetings as appropriate
Implement strategy across regions
Consultative – the candidate must be approachable and sought out for consultation by the business regarding their IT issues and challenges
Work closely with market advocacy teams and have visibility to all regulatory changes and initiatives
Regulatory Program Manager Examples
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Regulatory Program Manager Job Description
Job Description Example
Our growing company is hiring for a regulatory program manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory program manager
- Propose to stop the programme when it becomes clear that the intended benefits will not be realized
- Strong domain expertise in the securities settlement, asset servicing, and funds services areas with specialization in at least one of the above
- Good knowledge and understanding of the Investor Services business and some of the key market and regulatory changes impacting this business
- At least 10 years overall relevant experience
- Prince2 or PMI professional qualifications such as Certified Associate in Project Management (CAPM) (Preferable)
- Represent AM at IHC committee meetings, IHC CARMC, CCAR Challenge Sessions, Three Lines of Defense
- US and European regulatory affairs with some interface with global partners
- Determining regulatory paths for new product development, product and process change control
- Writing and/or submitting technical documents including 510(k)s, IDEs, PMAs, CE Technical Files/Dossiers and clinical trial protocols/updates
- Provide regulatory review/approval of labeling and act as liaison with FDA and the Notified Body in support of product approvals
Qualifications for regulatory program manager
- Given inherent complexity of all regulatory topics this will require dedicated analysis capability
- Support project teams with global regulatory strategies
- Monitor, research, and obtain information on FDA activities and proactively share information within Edwards
- Effectively communicate with regulatory agencies
- Expert knowledge of European regulatory requirements for Class IIa/b/III devices
- Provides strategic regulatory direction to teams on submission strategy, interaction and negotiation with regulatory agencies
2
Regulatory Program Manager Job Description
Job Description Example
Our company is looking for a regulatory program manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory program manager
- Provide advice and guidance to business leaders on the development of remediation plans to address internal audit and other findings regarding compliance with Regulations W and O
- Establish second line of defense monitoring requirements for compliance with Regulations W and O
- For projects assigned as DRA Lead, lead the development of submission of clinical trial applications world-wide, progress reports, amendments, and/or periodic experience reports
- Coordinates, reviews, and may prepare reports for submission
- May represent organization as prime technical contact on contracts and projects
- Support the strategic execution and maintenance of the BRQC (Bio Research Quality & Compliance) Regulatory Intelligence program
- Also support the strategic execution of other BRQC Regulatory Compliance activities including, inspections, special investigations, internal audits, support for ERC audits, compliance remediation
- As assigned or otherwise needed, assists relevant Regulatory Program Directors with their interactions, communications and planning with various other teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams
- Review RRG reporting and external regulatory and industry news to identify key supervisory developments and trends
- Participate in Divisional or Firm-wide initiatives/projects on behalf of GRRG, as appropriate (e.g., Firm Recovery/Resolution Communications Plan
Qualifications for regulatory program manager
- Achieving Results- Is goal-directed, persistent, driven to achieve objectives
- Organizations (ACO), PQRS, HEDIS, NQF
- Project management focused on Non Financial Regulatory Reporting (NFRR)
- Manages projects, processes within the NFRR program with cross business Partners with the business to develop and transition plans, including ongoing success measures, to sustain the change
- Accountable for initiatives, processes with cross –functional, inter-departmental line of business focus
- 3+ plus years of project management support experiences
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Regulatory Program Manager Job Description
Job Description Example
Our company is looking to fill the role of regulatory program manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory program manager
- Audit preparation for responsible standards
- Development of capital programs to support regulatory/compliance
- Support of FERC, NERC, NPCC, and ISO-NE standards and requirements
- Partners with regions to align on regulatory strategy in order to fullfill business objectives
- Represents DRA on or leads sub-teams as required
- Understanding existing KPIs, reporting and defining new KPIs, reporting with Business users to to meet the organization’s goals
- Defining the technical specification for KPIs and reporting, including how they link together in a 360 view
- Working with the offshore technical development team to implement
- Leading Change Management in the Q&R organization to utilize and embed KPIs and reporting into the organization’s way of working
- Working with the Enterprise Information Management (EIM) group on data modeling to ensure that the data model is complete and accurate
Qualifications for regulatory program manager
- Strong PC skills in Microsoft Suite
- Overall responsibility for Client Classification initiative (MIFID), multiple regulatory Initiatives, with a focus on Funds Services
- Responsible for engagement and management of DFS (Domestic Funds Services) Stakeholders (Product Management, Operations, other related IT teams such as channels)
- 3-4 years of regulatory experience, preferably with a strong knowledge of US regulatory affairs
- Full Lifecycle Project Management Experience with focus on planning/delivering deployment events with technical changes
- Proven experience on a global program/project with cross business involvement
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Regulatory Program Manager Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of regulatory program manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory program manager
- Review and approve Product Design Quality Records (DHF documents such as specifications, risk assessment reports, validation & verification test protocols/results/reports)
- As assigned or otherwise needed, assists relevant Regulatory Program Management Program Directors with their interactions, communications and planning with various other teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams
- Lead the Regulation W/O program of the Bank by providing advice and consultation to senior business leaders regarding nuanced Regulation W/O regulatory requirements
- Establish comprehensive and effective Regulation W/O internal controls based on regulatory requirements and major compliance obligations
- Provide thought leadership in the development of enterprise Regulation W/O policies and procedures, and oversee a team that works with business unit risk and control officers to implement cascading policies and procedures
- Lead a staff that works in partnership with business unit risk and control officers to ensure a robust first line of defense for Regulation W/O Compliance
- Chair the Regulation W Sub-committee of the Executive Compliance Committee
- Provide leadership on Regulation W/O issues within the Compliance Department and across the Bank
- Act as the voice of the Compliance Department on Regulation W/O issues in interactions with the Legal, Risk, Finance and other Departments
- Oversee the creation of Regulation W/O management and Board reports, and deliver such reports
Qualifications for regulatory program manager
- Supporting Global Compliance Regulatory Compliance Management Program and other assigned projects in planning and coordinating activities to ensure program / project goals and objectives are accomplished within approved schedule, scope and budget
- Managing programs / projects which contain material value (benefit / cost), complexity and uncertainty or managing sub-programs / sub-projects within a large program / project
- The preferred location for this position is at a J&J Operating company in Europe or Northeast US
- To ensure the definition, development, and implementation of best in class Regulatory Affairs processes, applied technologies, and regulatory quality standards
- Must be motivated to work independently with cross-functional teams
- Skill and determination to reach successful outcomes in negotiations with both inside team clients and outside parties , Regulatory agencies
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Regulatory Program Manager Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of regulatory program manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory program manager
- Plans and leadssafety, regulatory, accreditation and licensing program activities for compliance with the Washington State Department of Health (DOH), Conditions of Participation (CoPs) and other state and federal standards, rules and regulations in FMG Clinics
- Work with Technology managers and control functions leads to project and track ongoing scope and expense
- Lead monthly stakeholder meeting and draft monthly program updates
- Create program related presentations and analysis
- Work with management on special projects as they arise
- Enhances and manages medium-scale regulatory programs with generally-defined plans and delivery methodologies including continuous improvement activities and compliance related projects
- Supports IIA activity
- Define and report metrics (scorecards) on program progress, implementation and effectiveness
- Be responsible for continual staff and organizational readiness with regulatory compliance with TJC standards and CMS conditions of participation (COP)
- Maintain monthly tracer team activities
Qualifications for regulatory program manager
- Science based Bachelor or Master Degree with requisite experience and demonstrated capability
- Advanced degree (MD, PhD, PharmD) preferred
- Minimum 1 year experience in regulatory affairs
- Strong communication skills – verbal, written and technical (e.g., PowerPoint)
- Advanced proficiency with Microsoft Office (e.g., Excel, Word, PowerPoint, Visio, Project)
- Bachelor’s degree required (strongly prefer a degree in Biomedical Engineering, another Engineering discipline, Marketing, or a Science)