Medical Auditor

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

Benefits dieser Stelle

Competitive Compensation

Full Benefits Package

Ongoing Training and Development

Supportive Team Environment

Zusammenfassung

An established industry player is seeking a Medical Device Assessor to join their expanding team in a fully remote capacity. You will play a crucial role in ensuring compliance with European medical device regulations through audits and technical documentation reviews. This position offers a unique blend of fieldwork and in-depth assessments, ideal for professionals passionate about patient safety and product compliance. Join a supportive team that values ongoing training and professional development, and make a meaningful impact on medical technologies across Europe.

Qualifikationen

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

Aufgaben

• Conduct audits under ISO 13485 and MDR regulations.
• Review technical documentation for medical devices.

Kenntnisse

ISO 13485

MDR 2017/745

Technical Documentation Review

Auditing

Risk Management

Clinical Evaluations

Communication Skills

Organizational Skills

Ausbildung

University Degree in Engineering or Biomedical Sciences

Jobbeschreibung

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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
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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