Associate Director of Regulatory Affairs Job at EPM Scientific, San Diego, CA

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  • EPM Scientific
  • San Diego, CA

Job Description

A globally recognized medical technology innovator is seeking a strategic and experienced Associate Director of Regulatory Affairs to join their team in Southern California. This leadership role is essential in shaping regulatory strategies and ensuring compliance for cutting-edge medical devices across U.S. and international markets. The ideal candidate will bring deep regulatory expertise, a strong background in software-based medical technologies, and a passion for advancing health-care solutions.

The Associate Director should have the following qualifications:

  • Bachelor's degree in engineering, life sciences, or a related field (Master's preferred)
  • Regulatory Affairs Certification (RAC) strongly preferred
  • Minimum of 10 years of regulatory affairs experience in the medical device industry, including 5+ years focused on Software as a Medical Device (SaMD)
  • Demonstrated success in preparing and submitting regulatory applications (e.g., FDA, Health Canada)
  • In-depth knowledge of U.S., Canadian, and international medical device regulations
  • Proven ability to collaborate across functions including R&D, Quality, and Marketing
  • Strong communication, project management, and analytical skills
  • Willingness to work on site 4 days per week

Responsibilities of the Associate Director include:

  • Lead regulatory activities for new product development, labeling updates, and promotional submissions
  • Develop and execute regulatory strategies to support product approvals and global market access
  • Prepare and manage submissions including 510(k), EU MDR, and CE Mark documentation
  • Review and approve product labeling, advertising, and promotional content for regulatory compliance
  • Collaborate with internal teams and external consultants to ensure timely and successful project execution

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