Clinical Assessor
vor 16 Stunden
DNV MEDCERT, a leading certification body for ISO 13485 and recognized auditing organization under MDSAP, is seeking a skilled Clinical Assessor to join our team in Hamburg, Germany.
Key Responsibilities:- Support clinical evaluation assessments and prepare NB assessment reports for legal manufacturers' technical documentation according to MDR and MDCG CEAR requirements.
- Evaluate Periodic Safety Update Reports (PSUR) and Summary of Safety and Clinical Performances (SSCP) in accordance with MDR regulations.
- Review and approve clinical evaluation reports and other relevant technical documentation for accuracy and compliance with MDR requirements.
- Support reporting to European databases (CIRCABC/EUDAMED).
- Contribute to the development of the company culture within the Clinical Affairs Department.
- Academic degree in Medicine, Life Science, engineering, or a related 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 beneficial.
- Forward-thinking mindset and understanding of the Notified Body environment.
- Thorough, accurate, and risk-based working style.
- Excellent communication skills (verbal and written) in German and English.
DNV is an Equal Opportunity Employer and values diversity in the workplace. We invite you to be part of our inclusive culture.
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Hamburg, Hamburg, Deutschland DNV VollzeitAbout DNV MEDCERTDNV 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...
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