Compliance and Strategy Lead

7 dagen geleden


Utrecht, Utrecht, Nederland AMT Medical Voltijd

Unity Partners exclusively represents AMT Medical

AMT Medical is a leading medical device company that is transforming the future of cardiac surgery with the Elana Anastomotic System. This cutting-edge technology allows surgeons to perform a sutureless bypass on a beating heart without the need for a heart-lung machine, resulting in improved patient outcomes and faster recovery times. With offices in Utrecht (Science Park) and Ede, AMT Medical is expanding its team to support future growth and is seeking an experienced: RA Specialist .

In this pivotal role, you will be responsible for ensuring regulatory compliance for the Elana Anastomotic System, managing regulatory processes, and developing strong relationships with internal and external customers. You'll collaborate closely with Product Development teams to review Technical Documentation and provide feedback on compliance with international requirements.

Key Responsibilities:

  • Develop and execute pre- and post-market regulatory strategies to ensure compliance with international regulations.
  • Work closely with cross-functional teams to ensure regulatory compliance with e.g., standards, claims development, labeling, and promotional materials.
  • Prepare and manage regulatory documentation for submission to National Competent Authorities / Notified bodies.
  • Ensure regulatory labeling requirements specifications are met for new and modified products.
  • Provide regulatory guidance on Medical Device Regulations.

Qualifications:

  • A Master's degree in health science or life science field (e.g., biology, microbiology, chemistry, engineering, medical technology).
  • Minimum of 8 years' experience in RA, including MDR, PMA, and 510(k) submissions.
  • Experience with Class III Medical Devices, preferably cardiovascular devices.
  • Excellent communication skills in English.

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