Medical Auditor

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Darum lohnt es sich

Medical Device Assessor (Germany – Remote) 50% Auditing | 50% Technical Documentation Reviews Join a Growing German Notified Body We are expanding our Medical Device team and seeking experienced professionals to join a German Notified Body in a fully remote capacity.

What You'll Do • Conduct audits under ISO 13485 , MDR , and MDSAP , either remotely or on-site (limited travel) • Review Technical Documentation for active and non-active medical devices in line with MDR Annex II and III • Evaluate design dossiers, clinical evaluations, risk management, and sterilization processes • Prepare detailed assessment reports and issue certification recommendations • Collaborate with internal medical and regulatory teams on conformity assessments • Support clients through the certification process with clear, structured feedback • Maintain regulatory knowledge and participate in continuous internal training What You’ll Bring • A university degree in a relevant discipline: • For active devices : Electrical/Electronic Engineering, Software, Biomedical, Physics • At least 4 years of full-time experience in the medical device industry, including 2 years in design, manufacture, testing, or use of relevant devices • Strong understanding of ISO 13485 , ISO 14971 , and MDR 2017/745 • Experience performing audits and/or reviewing technical documentation for CE marking or MDSAP compliance • Prior experience working at or with a Notified Body is a strong advantage • Excellent written and verbal communication skills in English (German is a plus) • Strong organizational skills and the ability to work independently from a remote setup • Fully remote position (Germany-based) with minimal travel • Competitive compensation and full benefits package • A supportive, growing team within a well-established and expanding Notified Body • Ongoing training and professional development in auditing and regulatory topics • The opportunity to shape safer, more effective medical technologies across Europe Ready to join?

Apply with your CV in English and become part of a team ensuring medical devices meet the highest regulatory and safety standards. This is a unique opportunity to be at the forefront of European medical device regulation, contributing both through onsite/remote audits and technical documentation reviews for CE certification under MDR 2017/745 .

This role offers an ideal balance between field-facing auditing and in-depth file assessments, suited to individuals who want to make a meaningful impact on patient safety and product compliance.

Seniority level • Seniority level Mid-Senior level Employment type • Employment type Full-time Job function • Job function Quality Assurance • Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Strativ Group by 2x Get notified about new Insurance Auditor jobs in Germany .

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