Qualifications & Experience
- Within our Clinical Affairs team, you take responsibility for projects involving the gathering and structuring of clinical evidence and with a global focus. This includes:
- Defining the clinical strategy for our medical devices, and documenting Clinical Evaluation plans and reports
- Creating and maintaining up to date of Post-Market Surveillance Plans and Reports
- Performing systematic literature search to analyze the available clinical literature for a variety of medical devices
- You plan, implement, and execute the operational side of clinical investigations, communicating with your Clinical Affairs and Regulatory Affairs colleagues, and collaborating closely with product and market managers.
- You interact with all required external parties (hospitals, surgeons, authorities) involved in the projects and studies
- You interact with internal parties (Risk management, R&D, Regulatory Affairs, Marketing, Product Management, Quality Management) to close the loop with clinical evaluation and post-market surveillance and drive action and improvement where needed
- You write and review documentation in line with applicable requirements, such as EU Medical Device Regulation (EU MDR). You follow-up on industry trends and developments to continually update the clinical evaluation plans, and our governing procedures
- You have an academic degree in (life) sciences
- Ideally you have at least several years of previous professional experience in a regulated environment such as medical device industry in Regulatory Affairs, Quality or Clinical Affairs
- Ideally you have a comprehensive knowledge of European Clinical Evaluation guidelines and regulations (MEDDEV 2.7/1 Rev.4, EU MDR, MDCG guidelines)
- You have sound experience in scientific/medical writing demonstrated by authorship of scientific publications, or through similar professional experience
- You have excellent communication skills; full professional proficiency in English is required
- You have a pro-active mindset. You are a convincing communicator and are not afraid to suggest improvement possibilities
Interested? Send your resume and a short introduction of yourself to the email address behind the 'apply now' button!