About DNV MEDCERT

DNV MEDCERT is a leading certification body for medical devices, recognized for its expertise in auditing and certification of ISO 13485, MDSAP, and Medical Devices Regulation 2017/745. Our organization is committed to providing global market access by ensuring the safety and quality of products and systems to international standards and regulations.

Our Culture

We value a forward-thinking work environment, where employees are invested in and supported for continued development. Our high professional standards and sustainable approach guarantee a dynamic and engaging workplace.

Job Summary

We are seeking a Clinical Assessor to join our Clinical Assessment team in Hamburg, Germany. The successful candidate will report to the Head of Clinical Affairs and be responsible for supporting clinical evaluation assessments and preparing assessment reports.

Key Responsibilities

• Support the clinical evaluation assessments and prepare assessment reports of legal manufacturer's technical documentation according to the Medical Device Regulation (MDR) and MDCG CEAR.
• Evaluate Periodic Safety Update Reports (PSUR) and Summary of Safety and Clinical Performances (SSCP) according to the Medical Device Regulation.
• Review and approve clinical evaluation reports and other relevant technical documentation for accuracy and compliance with the Medical Device Regulation.
• Support reporting to European databases (CIRCABC / EUDAMED).
• Contribute to the development and support of the company culture within the Clinical Affairs Department.

Requirements

• An academic degree in Medicine, Life Science, engineering, or a related science field.
• Interest and relevant work experience in scientific documentation.
• Relevant clinical work experience in the regulatory environment of MDR, MDCG, MEDDEV, or ISO 14155 is an asset.
• A forward-thinking mindset and understanding of the Notified Body environment.
• A thorough, accurate, and risk-based working style.
• Good communication skills (verbal and written, German/English).

DNV is an Equal Opportunity Employer

We welcome applications from qualified candidates 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.