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. 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.
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:
* â–Ş For active devices: Electrical/Electronic Engineering, Software, Biomedical, Physics
* â–Ş For non-active devices: Biology, Biochemistry, Pharmacy, Chemistry, Medicine, etc.
* 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
💡 What’s Offered
* 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.