Werfen North America · 1 day ago
Regulatory Affairs Manager II Post Market
Bedford, MA
Full-time
Onsite
Senior Level
$160K/yr - $190K/yr
5+ years expWerfen North America is a family-owned, innovative company specializing in diagnostics. The Regulatory Affairs Manager II will lead the post-market regulatory program to ensure compliance for medical devices and manage a team of regulatory professionals.
Health CareManufacturing
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
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 preferred
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, preferred
Benefits
Medical, dental, and vision insurance
401k plan retirement benefits with an employer match
Paid vacation
Sick leave
Performance-based bonus
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America 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)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase