Regulatory Affairs Manager II Post Market Job at werfen (Bedford)

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

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Regulatory Affairs Manager II Post Market

Job Description

Job Responsibility

Requirements

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