Regulatory Affairs Specialist

4 weeks ago


Pleasanton, California, United States EPM Scientific Full time
Job Overview

We are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at EPM Scientific. This is an exciting opportunity to work with a leading medical device and diagnostics company, supporting their growing product portfolio.

Key Responsibilities:

  • Develop and implement regulatory strategies for global product approvals
  • Prepare and submit regulatory applications to FDA and international agencies
  • Coordinate and compile regulatory submissions, including EU dossiers and PMA supplements
  • Maintain annual licenses, registrations, and listing information
  • Act as subject matter expert for audits and inspections with internal and external authorities
  • Review and edit promotional materials
  • Stay up-to-date with medical device regulations and ensure submission requirements are current and accurate
  • Support product implementation by creating database licenses or reviewing/approving product release requests

Requirements:

  • Minimum 5+ years of experience with Class II and/or Class III medical devices
  • Experience authoring and submitting 510k applications and PMA supplements
  • RAC Certification
  • Experience with 21 CFR 820, ISO 13485, and relevant medical device directives
  • Strong technical writing skills
  • Familiarity with regulatory requirements for medical devices, including Quality Systems standards and clinical investigations
  • Ability to travel 5%, including international travel


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