Regulatory Affairs Manager II Post Market

Regulatory Affairs Manager II Post Market

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

1st

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Role

Summary:

The Regulatory Affairs Manager II leads the company’s post‑market regulatory program to ensure global compliance for commercialized IL-labeled medical devices and manages a team of regulatory professionals in this endeavor. This leadership role owns all elements related to post-market regulatory compliance to meet worldwide regulatory requirements, including vigilance reporting, recall (product correction and removal) management, on-market product change assessment, and the post-market surveillance (PMS) program.

The manager also develops people, builds processes, and represents Regulatory Affairs during management reviews, external and internal inspections and audits.

Key Accountabilities
- Essential Functions:

• 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.
• Participate, as the regulatory representative, in the risk analysis reviews for on-market device deficiencies to ensure the timely…