Director of Regulatory Affairs (Class III Medical Devices)
San Francisco, CA
Permanent Position
Competitive Salary & Benefits
About the company:
A mid-size and growing medical device manufacturer specializing in class III vascular devices are looking for an experienced Director of Regulatory Affairs to drive regulatory excellence in this field.
Position Overview:
They are seeking a Director of Regulatory Affairs to lead the regulatory efforts in achieving and maintaining RA compliance in US and EU markets.
As the Director of Regulatory Affairs, you will be responsible for developing and implementing regulatory strategies, ensuring compliance with global regulations, and supporting product development.
Key Responsibilities:
• Regulatory Strategy: Develop and execute regulatory strategies, considering regulations and industry trends to ensure market access and compliance.
• Global Compliance: Ensure compliance with FDA, EU MDR, and other international regulatory requirements for high risk medical devices. Manage submissions, including 510(k), PMA, and CE Marking.
• Cross-functional Collaboration: Collaborate closely with R&D, Quality Assurance, Clinical Affairs, and others to integrate regulatory requirements into product development processes.
• Regulatory Documentation: Prepare and review regulatory docs, including submissions, post-market reports, and technical documentation.
Qualifications:
• Bachelor's degree in a relevant field (Engineering, Life Science, Quality/Regulatory etc.).
• 10+ years of regulatory affairs experience in the medical device industry, with some experience in class III devices (ideally vascular).
• Strong knowledge of FDA regulations, EU MDR, and other global regulatory requirements.
• Proven track record of successful regulatory submissions and approvals.
Why Join?
• Join a forward-thinking company at the forefront of vascular access.
• Make a meaningful impact on patient outcomes and lives
• Collaborate with a talented and passionate team in a dynamic work environment.
• Competitive salary and benefits package.
• Strong career prospects and opportunity to grow with the business
To apply, please submit you’re an up to date resume. We look forward to reviewing your application.
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