Medical Device Safety Specialist
2 weeks ago
DNV Product Assurance AS is a leading Notified Body for medical devices. Their unit has the authority to carry out tasks related to the conformity assessment of medical devices before these products are placed on the market.
The Internal Clinician's role involves assessing clinical data to ensure the safety and performance of medical devices and/or in vitro diagnostic medical devices.
Main responsibilities:
- Conduct assessments and prepare reports on clinical data provided by manufacturers to ensure compliance with EU Regulations on medical devices and in vitro diagnostic medical devices.
- Evaluate summary of safety and clinical performance reports for high-risk devices.
- Review periodic safety update reports from manufacturers.
- Collaborate with external specialists during clinical data assessment of high-risk devices.
- Communicate with manufacturers regarding clinical data requirements.
- Finalize approval of clinical evaluation assessment reports and other relevant documentation for accuracy and compliance.
- Recommend certification based on reviewed documentation.
- Conduct competence review, training, and approval of new colleagues (clinicians).
- Medical Doctor degree required.
- At least 4 years of work experience including:
- 2 years of direct work experience in patient care preferably with surgery and/or laboratory medicine expertise,
- 2 years of research experience conducting preclinical or clinical trials or assessing clinical data.
- Strong technical skills essential.
- Analytical approach.
- Effective communication skills.
- Customer focus.
- Excellent reporting skills.
- Able to work independently and efficiently meeting deadlines.
- Able to make final decisions in complex cases.
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