Regulatory Affairs Manager II Post Market

Overview 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, i.e., 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.

• Regulatory & Analytical Rigor: Interprets complex regulations; synthesizes safety data into defensible reports.
• Communication: Clear, concise writing and agency‑facing communication; effective cross‑functional partnering.
• Leadership & People Development: Builds high‑performing teams; coaches for growth; manages performance and change.
• Problem‑Solving & Judgment: Navigates ambiguity; resolves compliance issues under time constraints.
• Inspection Readiness: Prepares teams and documentation; manages audits and remediation plans.

Minimum Knowledge & Experience Required for the Position:

• 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…