Staff Regulatory Affairs Specialist
Title: Senior Specialist/Manager of Regulatory Affairs
Summary:
A global leader in medical technology is seeking an experienced and driven Regulatory Affairs Specialist/Manager to join their team in California. This organization is dedicated to advancing medical innovations that improve patient outcomes, and this role offers the opportunity to contribute to shaping regulatory strategies and supporting groundbreaking product development. If you have strong communication and problem-solving skills and are passionate about regulatory affairs in the medical device industry, this could be the perfect fit.
The Manager should have the following qualifications:
- Bachelor's degree in health/life science or engineering field
- MUST have 5+ years of regulatory affairs experience in the medical device industry
- Proven track record with successful 510(k), EU MDR, and PMA submissions
- MUST be able to go onsite in California 4 days/week (multiple California locations
- Ability to work effectively with cross-functional and risk management teams
- IVD and CDx experience is preferred
Responsibilities of the Manager include:
- Ensure compliance with evolving regulations, including FDA Medical Device Regulations and EU-MDR, by supporting regulatory initiatives
- Monitor and interpret regulatory changes and international standards for U.S. and global markets, providing insights to relevant teams
- Oversee the consistent execution of Quality Management System (QMS) requirements from a regulatory perspective
- Prepare, audit, edit, and publish registration documentation in accordance with regulatory requirements
- Support business export control (BEC) listings, facilitating global product releases while maintaining compliance
- Review and approve product labeling, promotional materials, and advertising content to ensure adherence to regulatory standards
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