Auditor Jobs in Kornwestheim

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

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.