Clinical Evaluator (MDR) – Medical Devices Certification

DNV

Arnhem

On-site

EUR 65,000 - 95,000

Full time

4 days ago
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Benefits offered by this job

Competitive compensation
DNV training program
Professional community
Challenging projects
Competence network access
Local social benefits

Job summary

DNV Product Assurance AS is one of the world’s leading Notified Bodies for medical devices. The Internal Clinician role is to assess clinical data supporting the safety and performance of devices under MDR.

You will work with customers to ensure documentation meets regulatory requirements, plan evaluations, and contribute to certification decisions while collaborating with a professional team in a prestigious technical company.

Qualifications

  • Medical Doctor with relevant clinical experience.
  • Direct patient care experience required.
  • Experience researching preclinical or clinical trials.
  • Strong written and verbal English communication.

Responsibilities

  • Approve Certification Proposals for MDR-certified medical devices.
  • Assess and report clinical aspects of manufacturers' technical docs per MDR.
  • Plan and execute clinical evaluation assessments within timelines and budget.
  • Review safety and clinical performance reports for high-risk devices.
  • Approve clinical evaluation documentation for MDR compliance.
  • Recommend certification based on reviewed data.
  • Communicate requirements and status with customers.

Skills

Clinical data assessment
Patient care experience
English communication

Education

Medical Doctor

Job description

DNV Product Assurance AS is one of the world’s leading Notified Bodies for medical devices. The Internal Clinician role is to assess clinical data supporting the safety and performance of devices under MDR.

You will work with customers to ensure documentation meets regulatory requirements, plan evaluations, and contribute to certification decisions while collaborating with a professional team in a prestigious technical company.

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