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Werfen · 1 day ago

Regulatory Affairs Manager II Post Market

US-MA-Bedford

Full-time

Onsite

Senior Level

$160K/yr - $190K/yr

5+ years exp

Werfen is a growing, family-owned company specializing in diagnostics and medical devices. The Regulatory Affairs Manager II leads the post-market regulatory program to ensure compliance for commercialized medical devices and manages a team of regulatory professionals.

Health CareHospitalManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Lead, coach, and develop a team of post-market regulatory professionals (set goals, conduct routine performance reviews, create development plans)

Allocate resources and prioritize workload across markets/products for post-market regulatory activities

Monitor/trend staff performance; drive operational excellence

Represent the RA Bedford function internally and externally; cultivate professional relationships with regulatory agencies and industry groups

Lead team in assessing and documenting regulatory impact of design, labeling, and manufacturing changes to on-market devices

Lead team to develop and maintain a state-of-the-art Post-Market Surveillance (PMS) program that meets worldwide regulatory requirements

Lead team in the timely completion of PMS Plans/Reports per IVDR and worldwide regulatory requirements

Lead team compliance with FDA adverse event reporting (e.g., 21 CFR Part 803 – Medical Device Reporting) and other world vigilance reporting requirements

Lead field corrections and removal for on-market products, determining classification and regulatory agency reportability based on assessed risk, preparing comprehensive regulatory strategy, authoring field communication, leading cross-functional team to ensure timely customer notification, reporting and interfacing with regulatory agencies (as required), and supervising the regulatory team that assembles and maintains the necessary support records. Directly interfaces with US FDA and Health Canada customer base and regulatory agencies and supports international country affiliates and country dealers in meeting their country regulations and timelines

Review and approve labeling, advertising, and promotional materials for compliance; partner with RA Pre-Market/QA/Legal/Marketing to ensure alignment with labeled product claims and intended use

Support and lead inspections by external agencies (e.g., FDA, BSI) for areas managed, ie., vigilance, product corrections and removals, post-market surveillance, assessment of on-market product modifications

Monitor evolving global regulations, brief leadership and product teams on changes, impacts, and mitigation plans impacting regulatory post-market compliance

Participates, as the regulatory representative, in the risk analysis reviews for on-market device deficiencies to ensure the timely identification of potential reportable incidents and field corrections/removals

Identify compliance gaps and opportunities for improvements and assist the Senior Manager with updates to procedures and work instructions

Support the Senior Manager as needed

Qualification

Post-Market Regulatory ComplianceFDA RegulationsAdverse Event ReportingAnalytical SkillsLeadershipCommunication SkillsProblem-SolvingTeam DevelopmentInspection ReadinessRegulatory StrategyCross-Functional Collaboration

Required

Requires a Bachelor degree, preferably in regulatory or science related areas

Minimum of 5 years of management experience in the medical device or IVD industry

Experience with US FDA and Health Canada adverse event and field correction/removal regulations and guidelines required, with experience in international adverse event reporting and field correction/removal actions a major plus

Preferred

Experience in managing a post-market program

Knowledge of FDA 21 CFR 803, 806, 820, Health Canada Medical Device Regulation, European IVD Directive 98/79/EC and European IVD Regulation (EU) 217/746, MDSAP Companion Document and ISO 13485

Benefits

Medical, dental, and vision insurance

401k plan retirement benefits with an employer match

Paid vacation and sick leave

Performance-based bonus

Company

Werfen

Glassdoor4.0

Werfen is a developer, manufacturer and distributer of IVD testing solutions.

Founded in 1966

Barcelona, Catalonia, ESP

5001-10000 employees

http://www.werfen.com/

H1B Sponsorship

Werfen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (10)

2024 (12)

2023 (10)

2022 (2)

2021 (11)

2020 (8)