Integrated Clinician – Medical Device Certification
DNV · Espoo
Job description
About the role
DNV Product Assurance AS, a leading Notified Body for medical devices, is seeking an Integrated Clinician to assess clinical data that supports the safety and performance of medical devices under the EU Medical Devices Regulation (MDR).
Key responsibilities
- Approve certification proposals for medical devices according to the MDR.
- Assess and prepare clinical aspects of manufacturers' technical documentation.
- Plan and execute clinical evaluation assessments within agreed timelines and budgets.
- Evaluate and validate safety and clinical performance summaries for high‑risk devices.
- Review and approve clinical evaluation reports for accuracy and MDR compliance.
- Recommend certification decisions based on reviewed documentation.
- Communicate with customers regarding requirements, status, and clinically relevant issues.
- Conduct competence reviews of clinicians.
Required profile
- Medical Doctor with at least 2 years of relevant experience.
- Direct patient‑care experience and research experience in pre‑clinical or clinical trials, or assessing clinical data.
- Strong written and verbal English communication skills.
- Technical knowledge of medical devices and the MDR.
- Analytical mindset, excellent reporting ability, and ability to work independently and in a team.
Required skills
- Medical Device Regulation (MDR) assessment expertise.
- Clinical data evaluation and clinical evaluation report preparation.
What we offer
- Competitive compensation and benefits package.
- DNV training and qualification programmes.
- Opportunities to work on challenging, high‑impact projects.
- Access to an extensive competence network and professional community.
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Published 3 päivää sitten
Expires 1 kuukauden päästä
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DNV
Espoo
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