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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, seeking a Director of Regulatory Affairs to spearhead regulatory strategy and ensure compliance for their medical devices.

The successful candidate will possess a robust background in medical device regulations, especially within the realms of cardiology and electrophysiology.

Key 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

Qualifications:

  • A Bachelor's degree in a relevant scientific discipline; an advanced degree is preferred
  • Prior experience at a Director level is advantageous
  • In-depth understanding of US FDA and EU MDR regulations concerning medical devices
  • Experience with cardiac electrophysiology devices is highly desirable

We encourage qualified candidates to submit their applications directly.

Please be aware that due to the anticipated volume of applications, responses may be limited. If you do not meet the outlined criteria and do not receive a response within a specified timeframe, please consider your application unsuccessful.