International Compliance Manager

4 days ago


San Antonio, Texas, United States Extremity Care Full time
Job Description
Extremity Care is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our team, you will play a vital role in ensuring compliance with quality management systems and product realization.

Key Responsibilities:
  1. Ensure compliance with FDA and Health Canada regulations.
  2. Compile technical information for regulatory submissions.
  3. Support Marketing Material Development and Compliance with federal regulations.
  4. Manage unique device identifiers (UDI) submissions and regulatory compliance.
  5. Lead regulatory submissions for Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, International Registrations, etc.
  6. Evaluate changes to regulatory documents and formulate strategies to maintain submission goals.
  7. Maintain a working knowledge of relevant regulations and internal policies.

Why Join Us?
We offer a competitive salary range of $120,000 - $150,000 per year, depending on experience.

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