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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)