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Regulatory Affairs Manager II Post Market

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Location:
United States , Bedford

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

160000.00 - 190000.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • Lead, coach, and develop a team of post-market regulatory professionals
  • 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 and other world vigilance reporting requirements
  • Lead field corrections and removal for on-market products
  • Review and approve labeling, advertising, and promotional materials for compliance
  • Support and lead inspections by external agencies
  • Monitor evolving global regulations, brief leadership and product teams on changes, impacts, and mitigation plans
  • Participates, as the regulatory representative, in the risk analysis reviews for on-market device deficiencies
  • 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

Requirements:

  • 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
  • Experience in international adverse event reporting and field correction/removal actions a major plus
  • 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

Nice to have:

  • Experience in international adverse event reporting and field correction/removal actions
  • 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
What we offer:
  • Medical, dental, and vision insurance
  • 401k plan retirement benefits with an employer match
  • Paid vacation and sick leave
  • 10% Annual Bonus Target

Additional Information:

Job Posted:
January 12, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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