Integrated Clinician
DNV · Lisbonne
Descrição do cargo
About the role
DNV Product Assurance AS, a leading Notified Body for medical devices, is seeking an Integrated Clinician to evaluate clinical data and support the safety and performance assessment of medical devices under the EU Medical Devices Regulation (MDR).
Key responsibilities
- Approve certification proposals for medical devices in accordance with the MDR.
- Assess and report on clinical aspects of manufacturers' technical documentation.
- Plan, execute, and budget clinical evaluations within agreed timelines.
- Validate safety and clinical performance summaries for high‑risk devices.
- Review and approve clinical evaluation reports for accuracy and regulatory compliance.
- Communicate requirements, status, and clinical issues with customers.
- Perform competence reviews of clinicians and recommend certification decisions in complex cases.
Required profile
- Medical Doctor with at least 2 years of relevant experience.
- Direct patient‑care experience and background in pre‑clinical or clinical trial work.
- Strong written and verbal English communication skills.
- Analytical mindset with the ability to work independently and as part of a team.
Required skills
- Medical device knowledge.
- Clinical data assessment expertise.
- EU Medical Devices Regulation (MDR) expertise.
What we offer
- Competitive compensation and benefits package.
- DNV training and qualification programmes.
- Opportunities to work on challenging, high‑impact projects.
- Access to a broad competence network and professional community.
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Expira em 1 mês
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DNV
Lisbonne
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