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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.
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 regulato
