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Senior Regulatory Affairs ManagerBedford, MA
SummaryResponsible to manage the post-market regulatory activities required to maintain compliance to US FDA, Health Canada, European IVD Directive 98/79/EC and European IVD Regulation (EU) 217/746, MDSAP country regulations as well as other country regulatory agencies.
•Reviewing labeling and commercial materials and managing US FDA 510(k), HealthCanda Class II and III applications and amendments and EU Technical filesubmissions (as applicable)
•Post-market RA Manager: Provides regulatory leadership to meet post-marketrequirements, including but not limited to the management of field corrections andremovals, worldwide vigilance reporting, device modification assessments forregistration requirements and the post-market surveillance program to ensurecompliance with applicable domestic and international regulations.
Post-market RA Responsibilities:
- Acts as the regulatory representative, in the risk analysis worksheet (RAW) reviews for on-market product to identify potentially reportable incidents and field corrections/removals.
- Reviews and signs off verification protocols and reports for changes to on-market product, not requiring submissions.
- Manages the team that supports QA/RA Milan offices and IL affiliate offices for adverse event filings and responses to EU Competent Authorities in compliance with MEDDEV 2.12-1.
- Manages the timely filing of adverse events in the United States and Canada and also supports the affiliate countries in filing of adverse events per local regulations andtimelines (e.g. Australia, Brazil, Japan and S. Korea).
- Responsible for field corrections and removal for on-market product, authoring field communications, orchestrating the timely notification of customers and regulatory agencies (as required), preparing regulatory strategy, and supervising the team that assembles necessary support documentation and product information. Interfaces directly with US FDA and Health Canada and supports local affiliates and dealers in meeting their country regulations and timelines.
- Supervises the regulatory team to assess device modifications to IL-labeled medical devices, filing with US FDA and Health Canada directly (as needed), ensuring that necessary country regulatory filings and registrations are made prior to implementation in compliance with their local regulations (e.g. Australia, Brazil,Japan and S. Korea).
- Manages the post-market surveillance program in compliance with worldwide regulatory requirements. 17/1946 IVDR EU, China, Canada and others as requested.
- Supervises team that maintains FDA establishment registrations and device licenses, UDI database, Canadian license renewals and updates Health Canada in the event of a change in the ISO certificate per US and FDA regulations.
- Works with local affiliates in Australia, Brazil and Japan to ensure MDSAP country regulatory requirements are met and the documentation is available.
- Reviews commercial materials for regulatory compliance with registrations, including but not limited to brochures, presentations and training materials
- Reviews and signs Change Orders for on-market product.
- Develops and maintain regulatory related post-market procedures/policies.
- Other areas as needed to meet worldwide regulations.
- 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
- 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