Regulatory Compliance Specialist Job Description
Regulatory compliance specialist
provides regulatory guidance for maintenance related regulations such as 14 CFR Parts 21, 25, 43, 45, 91 and 121.
Regulatory Compliance Specialist Duties & Responsibilities
To write an effective regulatory compliance specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory compliance specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Efficiently managing multiple client relationships, monitor client satisfaction, ensure any client requests are managed on a timely basis
Mitigates regulatory, litigation and reputation risk to the firm as it relates to addressing client grievances and regulatory inquiries
Collaborates with department manager to build strong relationships with the Bank's regulators
50% - Quality Questionnaire management
This position will be a critical resource and subject matter expert regarding the hosting and execution of inspections, whether they be self-inspections or by external stakeholders such as US FDA, ISO Registrars and Notified Bodies
This position will also lead the coordination and management of a post-market compliance program that will include executing on the Quality System Policy (QSP) and associated SOPs regarding customer complaint management and adverse event reporting
Manages regulatory change compliance efforts within the Group as they relate to complex regulatory and policy requirements, program and project development
Analyses and identifies existing and proposed legislation, regulatory announcements, and industry practices, and helps businesses develop and implement procedures to meet these requirements
Ensure regulatory changes are reviewed each day, Draft overviews and change analysis statements to ensure changes are communicated/cascaded to relevant stakeholders
Liaise with legal, compliance, project management and the business lines to assess business impact and where deficiencies are reported, encourage and assist where required to ensure action plan development by the business
Regulatory Compliance Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Compliance Specialist
List any licenses or certifications required by the position: CISM, CISA, CISSP, PMP, CCSK, DSP, CCSP, ASQ, UGM, DOD
Education for Regulatory Compliance Specialist
Typically a job would require a certain level of education.
Employers hiring for the regulatory compliance specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Engineering, Science, Technical, Education, Business, Chemistry, Communication, Management, Project Management, Auditing
Skills for Regulatory Compliance Specialist
Desired skills for regulatory compliance specialist include:
Excel
312 and 812
45 CFR 46
ICH Good Clinical Practice guidelines
Regulations governing human research
Encryption and security monitoring
IPS
Modern microservices architectures and technology
Network protocols
HIPAA
Desired experience for regulatory compliance specialist includes:
Ensure accurate regulatory change compliance management Information reporting, providing up to date and relevant information to the boards within the Group
Solid understanding of Enterprise Compliance Risk Management and best practices
Strong knowledge of current regulatory change initiatives
Lead on the compliance monitoring activity across the organisation and provide compliance advice and guidance across the organisation
Assess the effectiveness of internal controls
Assist in identifying weaknesses and addressing these within agreed timelines and in accordance with relevant regulatory and internal policy requirements
Regulatory Compliance Specialist Examples
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Regulatory Compliance Specialist Job Description
Job Description Example
Our growing company is looking for a regulatory compliance specialist. 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 compliance specialist
- Instil and promote a compliance culture throughout the organisation and liaise cross-functionally across the organisation to ensure this as appropriate
- Support activity surrounding Import compliance
- Support activity surrounding US DOT Hazardous Materials Shipping
- Support activity surrounding to DEA Licensing for logistics centers and Year End Diversion tabulation
- Support maintenance of various databases
- Assist in the tracking, archival and retrieval of regulatory information for website submissions/licensing following instructions from supervisor
- Provide input and advice for labeling matters including assessment of regulatory requirements, labeling procedure requirements and labeling infrastructure
- Supporting the variation documentation preparation by facilitating timely provision of good quality source documentation and accurate comments from technical experts to Regulatory team
- Acting as member of the local change control review board and advise all contributors, including the site change coordinator on the regulatory relevance of change requests, provide general strategic regulatory support
- Keeping track with new regulatory requirements, Regulatory strategies and the knowledge of the global product dossiers
Qualifications for regulatory compliance specialist
- A minimum of three years' compliance experience in a wealth management or insurance context
- A minimum of two years' experience in a compliance monitoring function
- Hold a Third level degree - legal degree advantageous
- Strong team player but also able to self-motivate
- Develop an understanding to ensure compliance with the US
- Conduct timely and thorough regulatory reviews to support the widest possible commercialization of third-party products
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Regulatory Compliance Specialist Job Description
Job Description Example
Our company is growing rapidly and is hiring for a regulatory compliance specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory compliance specialist
- Mitigates regulatory, litigation and reputation risk to the firm as it relates to the various regulatory matter types
- Host customer audits on-site and via web sessions
- Provide integration direction for Quality System processes and sub systems
- Represent Quality Integration team in project team meetings
- Assist with problem-solving and coaching/mentoring related to the documentation of quality systems as required during the integration
- Reviews and approves controlled documents (SOPs, WIs and Forms) for the integration of quality systems
- Review changes to Corporate procedures and assess the impact on local site procedures
- Ensures compliance with company quality assurance policies and practices during integration
- Performs responsibilities required by the Quality System and other duties as assigned or requested from integration Project Managers
- Be a core team member of the QA Compliance team engaging in other QA compliance activities as required
Qualifications for regulatory compliance specialist
- Thorough knowledge of Financial Services rules and regulations
- Detail oriented with good time management, must be able to handle mutliple responsibilities simultaneously
- Bachelor's degree in Safety, Health, Industrial Hygiene, Environmental Management or closely related field
- 5+ years of professional, technical and/or utility operations experience
- BA or BS degree, with 3-5 years related experience in the medical device or pharmaceutical industry
- Advanced knowledge of relevant medical device and related laws and regulations
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Regulatory Compliance Specialist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of regulatory compliance specialist. 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 compliance specialist
- Provide direction and support to the business units throughout the development and preparation of filing materials
- Manage and coordinate the communication and negotiation of filings with state insurance departments in a manner that will result in timely approval of company products
- Apply problem-solving techniques to assist business unit personnel when responding to regulatory compliance issues
- Initiate timely implementation of changes of forms for various CorSo NA policy issuance systems by providing detailed instruction regarding programming and use requirements to ensure CorSo policy issuance compliance
- Respond to internal customer inquiries concerning items such as advance notice requirements, cancellation/non-renewal requirements, filing laws and other product compliance issues
- Ensure RFF tracking system is updated and accurate with current regulatory compliant product filing information
- Complete assigned or DOI requested state regulatory reports
- Review and analyze state insurance department statues, regulations, bulletins, to determine impact and ensure adherence to filing and regulatory requirements
- Manage, review and analyze ISO Circulars, determine impact to internal products and provide notification/explanation to business of changes
- Manage implementation of ISO changes in policy issuance system (Insurity)
Qualifications for regulatory compliance specialist
- Minimum of 2 years of regulatory compliance experience in the Medical Device industry is required
- Experience or knowledge of medical device labeling is a plus
- Proficiency in Adobe InDesign is a plus
- Auditor certification
- Documented continuing education in regulatory affairs or RAC Certification is a plus
- Must be able to occasionally travel t Gyrus ACMI facilities in the US
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Regulatory Compliance Specialist Job Description
Job Description Example
Our growing company is hiring for a regulatory compliance specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory compliance specialist
- Perform other related duties, including short or long term projects, as assigned by senior staff
- Analyze and interpret Department of insurance regulatory laws for development of compliant policies and implementation into policy issuance systems
- Responsible for policy issuance systems' filing compliance support as assigned
- Responsible for World-wide Field Actions and Recalls (Monthly Reports, Effectiveness Checks)
- Coordinate submission activities and internal and external communications for world-wide field action activities
- Assist in U.S. State Drug and Medical Device Licensing, Establishment Registrations, Device Listings (50 States), as needed
- Coordinates all procedures, training and systems to ensure compliance to regulatory processes for all Getinge products sold in the U.S. with emphasis on field action compliance
- Develop and maintain positive relationships with U.S. FDA, EU Notified Body and global regulatory agencies through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow‑up of submissions under review and field action requirements
- Develop and deliver presentations to global regulatory agencies
- Develop and implement strategies for regulatory approval of medical devices
Qualifications for regulatory compliance specialist
- Strong knowledge of ISO 13485/QSR requirements is highly preferred
- Must be able to analyze and resolve non-routine product issues using independent judgment with the assistance of engineering support when required
- 3-6 years experience in medical device with Bachelors, 1 year of experience with Masters degree, biologics and/or pharmaceutical field desired
- Bachelor’s or Master’s degree in engineering, life sciences or nursing (mechanical, electrical, industrial, software, biomedical, computer, biology, physics, chemistry, ) preferred
- Minimum undergraduate degree in engineering, physical or natural science, or other related technical discipline required
- Possess knowledge of how to research regulations that apply to Eatem Foods product portfolio
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Regulatory Compliance Specialist Job Description
Job Description Example
Our company is growing rapidly and is looking for a regulatory compliance specialist. 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 compliance specialist
- Research regulatory requirements for assigned geographies
- Review device labeling and advertising materials for compliance with submissions and applicable regulations
- Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities, field actions or review of proposed device changes
- Coordinate IFU development activities
- Participate in department/systems development initiatives
- Coordinates due dates of responses for Airworthiness issues with the Manager Regulatory Compliance (AW)
- Processes FAA requests such as log pages, EO’s, flight schedules, work orders, and provides them to the FAA as necessary
- Coordinates the corrective actions and completion of them to assure closure to LOI/CA corrective actions
- Coordinates the corrective actions and completion of them to assure closure VDR corrective actions
- Investigate formal and informal FAA concerns regarding manuals and operations, including on-site base, line and EMP investigations as assigned
Qualifications for regulatory compliance specialist
- B.Sc in Engineering, Sciences or equivalent preferred
- Knowledge of the Quality System Regulations (21 CFR), Medical Device Directives (MDD) and MEDDEV guidance
- 5+ years’ post-graduate work experience as a Quality and/or Compliance professional in a regulated industry role within a pharmaceutical /medical device trial environment, or within a Contract Research Organization (CRO)
- Must be methodical, well organized and detail oriented
- Conduct searches for international guidelines and standards
- Corresponds with test lab and third party agents with respect to testing, schedule, samples, paperwork