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Medical Auditor

Medical Auditor

Strativ GroupMunich , DE
Vor 30+ Tagen
Stellenbeschreibung

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 :
  • For active devices : Electrical / Electronic Engineering, Software, Biomedical, Physics
  • 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.

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