CM Medical is partnered with an exciting Cardiac EP start-up who are seeking a Director of Regulatory Affairs to lead regulatory strategy and compliance efforts for their devices.
The ideal candidate will have a strong background in medical device regulations, particularly in cardiology and electrophysiology.
Key Responsibilities :
- Develop and implement regulatory strategies for new and existing products
- Oversee FDA and EU regulatory submissions, including 510(k), De Novo, and CE Mark applications
- Ensure compliance with US FDA, EU MDR, and other relevant international regulations
- Lead and mentor the regulatory affairs team
Qualifications :
- Bachelor's degree in a relevant scientific field; advanced degree preferred
- Experience at Director level is preferred
- Extensive knowledge of US FDA and EU MDR regulations for medical devices
- Experience with cardiac electrophysiology devices preferred
To be considered for this position, please apply directly or email [email protected] with your resume and availability for a call.
Please note; I anticipate a lot of applicants and I'm simply unable to respond to all. If you do not meet the above criteria and haven't heard from me within 14 days of applying, please assume you have been unsuccessful.
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