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Head of Regulatory Compliance

2 months ago

California, United States CM Medical Recruitment Full time

CM Medical Recruitment is collaborating with an innovative start-up in the Cardiac Electrophysiology sector, looking for a Director of Regulatory Affairs to spearhead regulatory strategies and ensure compliance for their medical devices.

The successful candidate will possess a robust background in medical device regulations, with a focus on cardiology and electrophysiology.

Primary Responsibilities:

  • Formulate and execute regulatory strategies for both new and existing medical products
  • Manage submissions to the FDA and EU, including 510(k), De Novo, and CE Mark applications
  • Guarantee adherence to US FDA, EU MDR, and other pertinent international regulations
  • Guide and develop the regulatory affairs team

Required Qualifications:

  • Bachelor's degree in a relevant scientific discipline; advanced degree is advantageous
  • Preferred experience at the Director level
  • Comprehensive understanding of US FDA and EU MDR regulations applicable to medical devices
  • Experience with cardiac electrophysiology devices is highly desirable

We encourage interested candidates to submit their resumes for consideration.

Please be aware that due to the volume of applications, only those who meet the specified criteria will be contacted.