Medical Device Auditor & Technical Reviewer (Hybrid)

DEKRA Digital & Product Solutions; Arnhem; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive salary and comprehensive b

Bonus scheme

25 vacation days

13 ADV (Additional Days Off)

Travel and remote work allowances

Discount on insurance plans

Career growth programs

Challenging role in an international팀

Job summary

DEKRA Digital & Product Solutions in Arnhem seeks a mid-level medical auditor or technical file reviewer. You will conduct conformity assessments for high-risk medical devices, audit quality systems, and review technical files, collaborating with ~35 experts to ensure patient safety.

After internal training, you will travel 20-30% within Europe, maintain client contacts, represent DEKRA at conferences, and support regulatory activities.

Qualifications

• A Bachelor's or University level degree in life- and/or engineering sciences is a must.
• Minimum of 4 years of full-time work experience in the medical device industry, incl. 2 years in R&D or QA/Regulatory.
• Experience with CE and quality management systems is required.

Responsibilities

• Independently execute audits and processes.
• Assess technical files and audit quality systems for customers from startups to multinationals.
• Act as linking pin and maintain contact with customers, experts, contractors and authorities.
• Represent DEKRA at conferences when required.
• Travel within and outside Europe, about 20-30% of the time.

Skills

Auditing

Quality systems

Regulatory affairs

Product safety

English skills

Education

Life/Engineering sciences degree

Job description

DEKRA Digital & Product Solutions in Arnhem seeks a mid-level medical auditor or technical file reviewer. You will conduct conformity assessments for high-risk medical devices, audit quality systems, and review technical files, collaborating with ~35 experts to ensure patient safety.

After internal training, you will travel 20-30% within Europe, maintain client contacts, represent DEKRA at conferences, and support regulatory activities.