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Chief Compliance Officer for Medical Devices
3 weeks ago
We are seeking a Director of Regulatory Affairs with a strong strategic vision and leadership capability to join our executive team.
About the Job:- Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities.
- Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines.
- Serve as the primary liaison with regulatory authorities, representing us in all regulatory interactions and negotiations.
The ideal candidate will have a minimum of 10 years experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role. Proven success in preparing and leading regulatory submissions for Class II/III devices (EU MDR and FDA pathways essential). Strong understanding of the global regulatory environment, including emerging markets.
Required Skills and Qualifications:- Minimum of 10 years experience in Regulatory Affairs within the medical device industry.
- At least 3 years in a leadership role.
- Proven success in preparing and leading regulatory submissions for Class II/III devices.
- Strong understanding of the global regulatory environment, including emerging markets.
A senior leadership role with real influence across the business. Competitive salary, equity participation, and an attractive benefits package.
About Us:An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits.
