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Utrecht, Utrecht, Nederland AMT Medical Voltijd

Unity Partners exclusively represents AMT Medical

As a dynamic scale-up, AMT Medical is poised to redefine cardiac care by transforming Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. This minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without the use of a heart-lung machine, reducing patient impact and shortening recovery time.

The company has completed a large-scale clinical trial for the Elana Anastomotic System and will soon publish the results. With offices in Utrecht (Science Park) and Ede, AMT Medical is expanding its team to support future growth. We are looking for an experienced: RA Specialist .

In this critical role, you will be responsible for ensuring compliance for the Elana Anastomotic System, driving regulatory processes, and developing strong relationships with internal and external customers. You'll work 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.
  • Collaborate 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.