Hybrid/full-remote available. More interested in the right candidate, not where they're located.
Internal Number: 201661
The Sr Regulatory Affairs Manager is responsible for supporting the development and operations team’s compliance with FDA, CLIA, CAP, IVDR, and other global regulatory requirements. This position will be responsible for working cross-functionally to support key regulatory submissions as well as interfacing with regulatory authorities and key business partners.
Key Responsibilities and Essential Functions
(Oversees or Manages) regulatory filings for new product introductions, and expanded indications, including providing guidance for requirements and authorizing/reviewing regulatory filing documentation
Oversees/Manages submissions in multiple ex-US jurisdictions, including the EU, APAC, Australia, and assume regulatory responsibility for compliance with IVDR.
Develops and executes change notification strategies for changes to registered products, both in the U.S. and globally
Contributes to agency communications in the event of notifiable non-conformances or adverse events
Owns and manages applicable regulatory processes and documents
Works with quality system process owners to identify and interpret applicable regulations and to mitigate any gaps
Reviews incoming project agreements and provide guidance for regulatory requirements for projects
Informs the cross functional team of any new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product and provide the appropriate data to the Project Lead to prepare Post Launch Monitoring Annual Report
Bachelors + 12 years of related experience, or Masters + 8 years of related experience, or PhD + 5 years of related experience
Masters or PhD strongly preferred
6+ years of regulatory experience in a medical device and/or diagnostics company involved with development, manufacturing, testing and distributing products or similar experience
Experience managing regulatory filings with the FDA, EU, and other ex-US regulatory bodies is highly preferred.
Experience with U.S. and international IVD regulations
Broad knowledge of post market surveillance regulations, practices, and procedures