Medical Auditor

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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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