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Regulatory Affairs Specialist

4 months ago

Palo Alto, United States Net2Source Inc. Full time

Job Title: Regulatory Affairs Professional 4

Duration: 12 months (Possible Extension )

Location: Palo Alto CA 94304 (Hybrid)


Experience: 5-8 years.

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.

Experience with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.