Technical Writer & Clinical Specialist | Utrecht area

Descripción del puesto:

Heb je ervaring met Clinical Evaluation of Technical Writing binnen de Medical Device industrie, en heb je een uitstekende beheersing van het Engels (zowel schriftelijk als mondeling)? Dan horen we graag van je.
I am currently recruiting a Technical Writer & Clinical Specialist to join an international Medical Device company in the Utrecht area.
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.
Reportin to the R&D Director, you will work closely with R&D, Quality Assurance and Regulatory Affairs teams, ensuring that technical and clinical documentation remains compliant throughout the product lifecycle.
You will collaborate closely with another Technical Writer & Clinical Specialist. This newly created role will strengthen the team as the company continues to grow.

Key Responsibilities:
* 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

Profile:
* 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

Salary & Benefits:
* Annual salary up to 70kEUR based on profile and experience
* 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)

Send your CV to t. perriaux@eurolondon. com
Only shortlisted candidates will be contacted
Check our offers on Euro London website
#MedicalDevices #QualityAssurance #UtrechtJobs #TechnicalWriting