RA Specialist

Unity Partners exclusively on behalf of our partner, AMT Medical

AMT Medical is a Class III medical device company that is transforming Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. Their 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. AMT has finished patient inclusion of a large-scale clinical trial in 2024 and the results will become available in 2025. The offices are in Utrecht (Science Park) and in Ede. As AMT continues to grow, we are looking for a: RA Specialist.

In this critical role, you will ensure compliance for the Elana Anastomotic System, drive regulatory processes and activities, and continue to develop strong relationships with internal and external customers. You’ll be responsible for managing regulatory aspects of new product development, product life cycle and changes to existing products.

You will report directly to Maarten Arends, the Quality and Regulatory Director.

Key Responsibilities:

• Develop and execute pre- and post-market regulatory strategies and international requirements.
• Work closely together with Product Development teams, reviewing the Technical Documentation and provide feedback on compliance with e.g. standards, claims development, labeling, and promotional materials.
• Prepare and manage regulatory documentation for submission to National Competent Authorities / Notified body.
• Prepares regulatory labeling requirements specifications for new and modified products, and reviews and approves product labeling to ensure compliance.
• Part of cross-functional teams by providing regulatory guidance in the understanding of 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’ RA experience (e.g., MDR, PMA, 510(k) submissions).
• Experience with Class III Medical Devices. Cardiovascular devices is a plus.
• Excellent communication in English.

Organization & Offer:

Join AMT Medical, a dynamic scale-up poised to redefine cardiac care. Positioned at the forefront of innovation, AMT offers a collaborative and flexible work environment where your contributions significantly impact patient outcomes. AMT Medical offers a competitive salary and benefits package, along with substantial opportunities for professional growth and development.

How to Apply:

Interested candidates are invited to send their CV and a cover letter to our recruiter, Christian Steenkamp, at Unity Partners:

• Email: christian@unitypartners.nl
• Phone: +31 20 89 38 606 Please include Job ID: AMT05032025/3 in all communications.