Clinical Assessor

About us

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

About Life Sciences

We help our customers in medical devices, healthcare, and aquaculture/ocean industries build trust and transparency across their products, assets, and supply chains. By working with customers to certify medical technologies, support safe and sustainable healthcare practices, and advance responsible aquaculture and ocean stewardship, we help manage risks, meet regulatory demands, and achieve long-term goals. Drawing on deep technical expertise, we partner with customers worldwide to bridge trust gaps between patients, providers, producers, and consumers—driving sustainable results and improved ESG performance.

About the role

Clinical Assessment

• Review and assess Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), and supporting clinical evidence.
• Evaluate the adequacy, scientific validity, relevance and consistency of clinical data supporting device safety, performance and clinical benefit.
• 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 clinical evidence with the device’s intended purpose, indications and target population.
• Identify gaps, deficiencies, inconsistencies and regulatory non-conformities in submitted documentation.

Assessment Delivery and Collaboration

• Prepare clear, evidence-based, technically sound and timely assessment reports and conclusions.
• Participate in multidisciplinary MDR/IVDR conformity assessment teams within the scope of assigned competence.
• Communicate assessment findings and requests for clarification effectively to internal stakeholders and customers, as applicable.
• Collaborate with relevant technical and clinical experts when specialist input is required.
• Plan and manage assigned assessments to meet agreed quality and delivery expectations.

Competence and Continuous Improvement

• Maintain current knowledge of applicable medical device regulations, guidance documents, clinical research methods and relevant therapeutic developments.
• Complete required training, qualification and competence maintenance activities.
• Contribute to the improvement of assessment methods, templates and internal processes.
• Perform other reasonable duties assigned by the line manager.

What we offer

• Flexible work arrangements for better work-life balance
• Generous Paid Leaves (Annual Paid Leave, Sick Leave)
• Medical benefits (Standard medical check-up)
• Pension and Insurance Policies
• Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)
• Additional Benefits (Long Service Awards, Mobile Phone Reimbursement, Professional Membership Fees)

*Benefits may vary based on position, tenure/contract/grade level*

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.

About you

Education

• Bachelor’s degree or above in Clinical Medicine.。
• A master’s degree, doctoral degree, recognized medical qualification or physician practice experience is an advantage.

Required Experience

• At least four years of hospital-based clinical practice experience.
• Sound knowledge and practical understanding of one or more relevant therapeutic areas.
• Familiarity with clinical research principles, study design and Good Clinical Practice (GCP).
• Demonstrated ability to search, read, interpret and critically evaluate clinical and scientific literature.
• Good English reading, writing and verbal communication skills, including the ability to review scientific and technical documentation in English.
• Strong communication and interpersonal skills.

Preferred Experience

• Experience involving medical devices, in vitro diagnostics, clinical investigations, clinical research organizations, regulatory affairs or quality management.
• Knowledge of EU MDR, EU IVDR, ISO 13485, relevant MDCG guidance or other medical device regulatory frameworks.
• Experience preparing or reviewing clinical evaluation, performance evaluation, PMCF/PMPF or post-market surveillance documentation.

Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices..