Position Overview

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

Required

• 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

Preferred

• 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