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Medical consultant • ratingen
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ONE HIRINGGreater Dusseldorf Area, GermanyMedical Auditor
Strativ GroupDüsseldorf, DEMedical 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
What’s Offered
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.