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Technical Writer & Clinical Specialist

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Euro London Appointments

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Location:
Netherlands , Utrecht

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

70000.00 EUR / Year
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Job Description:

In this role, you will be responsible for developing and maintaining technical and clinical documentation for medical devices, while supporting Clinical Evaluation (CER), Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS) activities in line with ISO 13485, MDR and MDD regulations.

Job Responsibility:

  • Write, edit and maintain technical documentation related to medical device development
  • Contribute to Clinical Evaluation activities, including Clinical Evaluation Reports (CER) and PMCF documentation
  • Support Post-Market Surveillance (PMS) activities and clinical follow-up processes
  • Translate complex technical or scientific information into clear documentation for different audiences, including Instructions for Use (IFU)
  • Coordinate the review and approval of documentation with subject matter experts and internal departments
  • Support regulatory reporting activities, including vigilance and adverse event reporting
  • Participate in internal and external audits related to clinical evaluation and documentation
  • Contribute to risk management activities, integrating clinical and post-market data into risk management files
  • Perform scientific literature reviews to support clinical evaluation and regulatory documentation

Requirements:

  • Fluent English
  • Experience in Technical Writing or Clinical Evaluation within the Medical Device industry
  • Experience working with CER, PMCF or PMS documentation
  • Good understanding of ISO 13485, MDR and MDD regulatory frameworks
  • Experience preparing technical documentation for medical devices
What we offer:
  • Annual bonus of 10% depending on company’s target
  • 2 days Working From Home policy
  • Pension scheme Defined Benefit Plan until 2028 (transition to Defined Contribution Plan)

Additional Information:

Job Posted:
March 19, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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