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RA Specialist

RA Specialist

StandorteAmsterdam, Netherlands
Kontakt E-Maila.brenner@panda-int.com
Job ref21510
Publiziert2 months ago

I'm currently seeking a talented Regulatory Affairs for our client - a leading European Medical Device manufacturer in Amsterdam, specializing in innovative products that ensure the safety and effectiveness of healthcare practices across Europe. 


  • Collaborate with Product Management to develop regulatory strategies and drive new product development initiatives.
  • Collect, 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 collaboration with a Notified Body.
  • Monitor external changes to related standards and assess their impact on the company's regulatory practices.
  • Provide guidance and information on Quality Assurance and Regulatory Affairs to internal stakeholders.
  • Maintain relationships with clients and suppliers, addressing quality and regulatory concerns.


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

Company Offer:

Our client offers a competitive salary and benefits package, along with ample opportunities for personal development and career progression. Join their mission to improve patients' lives across Europe while advancing your career in the regulatory environment.

Interested? Contact Aimee Brenner for more information at +31 (0)20 20 44 502 or via email at a.brenner@panda-int.com.