Associate Director of Regulatory Affairs
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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