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Regulatory Affairs Specialist

Regulatory Affairs Specialist

LocationAmsterdam , Netherlands
Business SectorMedical Devices
Contact nameAimee Brenner
Contact email
Job ref22247
Published13 days ago

A leading company in the Software and AI medical device company  in Amsterdam and Rotterdam I'm looking for a Regulatory Specialist. This role involves orchestrating regulatory efforts to ensure optimal interactions with regulatory bodies and achieve regulatory approval for medical devices.


  • Prepare regulatory documents like pre-submission requests and marketing clearance requests.
  • Independently prepare document packages for regulatory submissions, including 510(k)s, Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions, and Pre-market Approval Applications.
  • Track and coordinate regulatory submission activities to ensure timeliness and commitments are met.
  • Coordinate responses to regulatory agencies and notified bodies during the submission and approval process.
  • Review and approve Engineering Change Orders in line with regulatory requirements.
  • Review and approve test protocols supporting regulatory submissions.
  • Ensure device labeling and advertising materials comply with regulatory submissions.
  • Assist in regulatory compliance activities, including Notified Body Audits, FDA Inspections, and other regulatory agency inspections and audits.
  • Maintain regulatory files and perform internal audits of the Quality Management System.
  • Provide ongoing regulatory support and guidance to project teams.
  • Interpret and apply regulations and guidance appropriately.


  • Bachelor's degree in a relevant field.
  • At least 5 years of experience in regulatory affairs within the medical device, biotech, or pharmaceutical environment.
  • Knowledge and experience with ISO 13485, ISO 14971, 21 CFR 820, and IEC 62304.
  • Strong written and oral communication skills.
  • Familiarity with GMPs and GCPs.
  • Experience with regulatory submissions in the US and EU, including 510(k), PMA, DeNovo, and/or Technical Files.


  • Master’s Degree in Engineering, Quality, Regulatory, or related field.
  • Prior experience working at the FDA.
  • Regulatory compliance experience in the medical device area.
  • Strong negotiation, communication, organizational, and time management skills


  • Unique opportunity to contribute to the regulatory success of innovative medical device products in a dynamic and challenging environment.
  • Hybrid working from both Rotterdam or Amsterdam office
  • Competitive market salary and interesting secondary benefits


Interested applicants are encouraged to apply immediately by sending their CV to Aimee Brenner at a.brenner@panda-int.com. This is an excellent opportunity to join a leading pharmaceutical company in a vital role, so act fast to secure your chance for an interview.