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(2) Sr. Regulatory Affairs Specialist

2 months ago

Minneapolis, United States Custom Search Full time

Our mid-sized medical client is adding a Sr. Regulatory Affairs Specialist to their team The Sr. Regulatory Specialist will support international registrations and renewals as well as PMA work . This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific products and ensures compliance with required regulations and established corporate standards.

Your role with the company:

  • Prepare documentation for international regulatory registration
  • Prepare technical documentation compliant to MDD and EU MDR
  • Submission for PMA, line extensions
  • Define worldwide regulatory requirements necessary for regulatory approval of assigned products
  • Participate on cross functional teams as regulatory lead
  • Complete worldwide regulatory assessments and change orders
  • Execute product submission strategies as directed
  • Maintain all regulatory documentation to ensure availability for external audits and preparation of submission packages
  • Review protocols and reports for scientific validity and compliance to regulatory standards and provide scientific judgement to guide cross functional teams.
  • Author submissions, research requirements, set priorities and maintain project schedulesProvide guidance and oversight to team members related to regulatory compliance
  • Review marketing literature for compliance to applicable regulations
  • Maintain a thorough knowledge of current regulatory requirements
Desired Profile:
  • BS degree in Science or Engineering
  • 5+ years experience in Regulatory Affairs in the medical device industry
  • Through understanding of international submission requirements including how to comply with standards and regulations
  • Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel
  • FDA, EU, Health Canada, TGA, PMDA, and international market submission experience needed