Regulatory Affairs Professional

4 weeks ago


Palo Alto, United States Cygnus Professionals Full time

Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches

  • Product Registration Experience: Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files
  • Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.
  • Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
  • Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO 10993-1 as evidenced by coursework or submissions that required use of each standard

Teamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.

Regulatory Affairs Professional
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