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Regulatory Affairs Specialist

Regulatory Affairs Specialist

LocationUtrecht, Netherlands
Business SectorMedical Devices
Contact nameChristian Steenkamp
Contact emailc.steenkamp@panda-int.com
Job ref20716
Published18 days ago

Currently, I’m looking for a RA Specialist to join a leading European Medical Device manufacturer. As a member of the RA/QA team, you will play a key role in ensuring the safety and effectiveness of their products, which are used by healthcare professionals across Europe.



  • Collaborate with Product Management to develop regulatory strategies and drive new product development
  • Collect, register, maintain, and distribute technical files for private label products in compliance with applicable laws and regulations
  • Review and update technical files for self-certification and certification in cooperation with a Notified Body
  • Monitor external changes to related standards and assess their impact on the company
  • Provide QA/RA guidance and information to internal stakeholders
  • Maintain relationships with clients and suppliers regarding quality and regulatory aspects



  • Bachelor’s degree in a scientific or technical discipline, preferably with a biomedical or pharmaceutical background
  • At least 2 years of experience in regulatory affairs for medical devices, with knowledge of MDR, ISO 13485, ISO 14971, ISO 10993, and quality systems
  • Experience with technical file preparation and maintenance
  • Familiarity with vigilance, monitoring, and complaint handling during the product life cycle



If you are a talented professional with a passion for ensuring patient safety and want to work in a dynamic, international team, this is the right match. Join the company in its mission to improve patients' lives across Europe while advancing your career in the regulatory environment.

The company offers a competitive salary and benefits. Besides that, there are a lot of opportunities for personal development and career progression.


INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or c.steenkamp@panda-int.com