Clinical Assessor (Medical Devices)

About the role

DNV, an independent expert in assurance and risk management, is hiring a Clinical Assessor for its Life Sciences business, which supports medical devices, healthcare and aquaculture/ocean industries. The assessor reviews and evaluates clinical evidence supporting device safety, performance and clinical benefit, and works within MDR/IVDR conformity assessment teams.

Key responsibilities

• Review and assess Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs) and supporting clinical evidence, judging the adequacy, scientific validity, relevance and consistency of the data.
• Critically appraise scientific publications, literature reviews, clinical investigation reports, performance study reports and post-market clinical evidence.
• Assess clinical benefit-risk conclusions and the alignment of evidence with the device's intended purpose, indications and target population.
• Identify gaps, deficiencies, inconsistencies and regulatory non-conformities in submitted documentation.
• Prepare clear, evidence-based, technically sound and timely assessment reports and conclusions.
• Participate in multidisciplinary MDR/IVDR conformity assessment teams within assigned competence, and communicate findings and requests for clarification to internal stakeholders and customers.
• Collaborate with technical and clinical experts when specialist input is needed, and plan and manage assigned assessments to meet quality and delivery expectations.
• Maintain up-to-date knowledge of medical device regulations, guidance documents and clinical research methods, complete required training and contribute to improving assessment methods and internal processes.

Required profile

• Bachelor's degree or above in Clinical Medicine; a master's, doctoral degree, recognised medical qualification or physician practice experience is an advantage.
• At least four years of hospital-based clinical practice experience.
• Sound knowledge of one or more relevant therapeutic areas.
• Familiarity with clinical research principles, study design and GCP.
• Ability to search, read, interpret and critically evaluate clinical and scientific literature, and good English reading, writing and verbal skills.
• Preferred: experience with medical devices, IVD, clinical investigations, clinical research organisations, regulatory affairs or quality management, and familiarity with EU MDR, EU IVDR, ISO 13485, MDCG guidance or post-market surveillance documentation.

What we offer

• Flexible work arrangements for better work-life balance.
• Paid leave (annual paid leave and sick leave).
• Medical benefits (standard medical check-up).
• Pension and insurance policies.
• Training and development assistance, including training sponsorship and on-the-job training.
• Additional benefits such as long service awards, mobile phone reimbursement and professional membership fees.