Medical Auditor

Strativ Group; München; Remote; EUR 50.000 - 90.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Medical Device Assessor to join their growing team in a fully remote capacity. This role is pivotal in ensuring compliance with European medical device regulations, offering a blend of auditing and technical documentation reviews. Ideal candidates will bring extensive experience in the medical device sector, particularly with ISO standards and regulatory compliance. You will have the chance to make a significant impact on patient safety and product compliance while enjoying a supportive work environment and opportunities for ongoing professional development. If you're ready to contribute to safer medical technologies across Europe, this role is for you.

Leistungen

Competitive Compensation

Full Benefits Package

Ongoing Training

Professional Development

Supportive Team Environment

Qualifikationen

• 4+ years in the medical device industry, with 2 years in design or testing.
• Strong knowledge of ISO standards and MDR regulations.

Aufgaben

• Conduct audits under ISO 13485 and MDR, either remotely or on-site.
• Review technical documentation for medical devices for CE certification.
• Prepare detailed assessment reports and issue certification recommendations.

Kenntnisse

ISO 13485

MDR 2017/745

Auditing

Technical Documentation Review

Risk Management

Clinical Evaluations

Electrical Engineering

Biomedical Engineering

Software Engineering

Organizational Skills

Ausbildung

University Degree in Relevant Discipline

Jobbeschreibung

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
• 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.