Technical Writer & Clinical Specialist
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Job Location:
Soest - Netherlands
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Job Description
TECHNICAL WRITER & CLINICAL SPECIALIST MEDICAL DEVICES
WHAT YOU WANT TO KNOW
- Location: Soesterberg Netherlands
- Working pattern: Hybrid (3 days on-site 2 days remote)
- Salary: 55000 - 75000
- Contract: Permanent
- Department: Research & Development
This position combines technical documentation clinical evaluation and post-market surveillance responsibilities within a regulated medical device environment.
The role works closely with R&D Regulatory Affairs QA and product teams ensuring technical documentation and clinical processes meet international regulatory requirements including ISO 13485 MDR and MDD.
JOB DETAILS
Our client is seeking a Technical Writer & Clinical Specialist to support the development maintenance and improvement of technical documentation related to medical device products.
This position plays a key role in ensuring documentation used internally and externally including Instructions for Use technical files and development documentation is accurate compliant and aligned with regulatory requirements.
Alongside technical documentation the role will support Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF) activities contributing to regulatory submissions audits and risk management processes.
The position sits within the R&D function and collaborates closely with Quality Assurance Regulatory Affairs and product development teams.
ROLES & RESPONSIBILITIES
Technical Documentation
- Write edit and review technical documentation related to medical device development
- Translate complex technical information into clear and structured documentation
- Create and maintain documentation for product users including Instructions for Use (IFU)
- Coordinate internal review and approval processes for technical documentation
- Work closely with subject matter experts to ensure accuracy and completeness of documentation
Clinical Evaluation & PMCF
- Support Clinical Evaluation and PMCF activities in compliance with MDR and ISO standards
- Contribute to Post-Market Surveillance activities
- Assist with regulatory reporting including vigilance adverse events and FSCA reporting
- Support internal and external audits related to clinical evaluation and PMCF processes
Risk Management & Regulatory Support
- Provide clinical evaluation input to risk management processes
- Support Regulatory Affairs in preparing technical documentation for regulatory submissions
- Update risk management documentation based on clinical evaluation findings
Documentation & Process Improvement
- Improve documentation processes and storage systems
- Identify opportunities to optimise documentation workflows
- Contribute to continuous improvement initiatives across the organisation
Cross-Functional Collaboration
- Work with internal teams and external stakeholders on product development projects
- Conduct literature reviews to support clinical and regulatory activities
- Provide training and guidance on clinical evaluation and PMCF requirements
ESSENTIAL EXPERIENCE
- Minimum 5 years experience in technical writing within a regulated industry
- Experience within the medical device sector
- Strong understanding of clinical evaluation and PMCF processes
- Familiarity with ISO 13485 MDR and MDD regulatory frameworks
- Experience producing technical documentation for multiple audiences
QUALIFICATIONS
- Bachelors or Masters degree in a technical engineering life sciences or related discipline
- Additional education or training in medical device regulation clinical evaluation or quality management is advantageous
- Technical writing certification or equivalent professional experience is beneficial
Required Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- Content Management Systems
- Technical Writing
- Visio
- Microsoft Powerpoint
- Sharepoint
- XML
- Confluence
- Wiki Systems
- Word Processing
- Writing Skills
