Medical Devices Expert & Auditor

DEKRA Automobil GmbH; 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

Key Area: Product Testing & Laboratory Services

Level of Experience: Mid Level

Employment Type: Fixed Term Contract (≥ 6 Months) with Sequence Num

Full Time / Part Time: Full Time

Weekly Hours: 40.00

Remote Working: Hybrid

What will your role involve

The Medical division is a leading and fast-growing Notified Body within the Medical Device Industry. Consequently, we are consistently looking for medical auditors or technical file reviewers. Dealing with cutting-edge medical innovations, we provide our clients with worldwide market access through executing conformity assessments for high-risk devices. We collaborate with a team of approximately 35 experts based in our office in Arnhem, all with the ultimate goal to ensure patient safety for medical devices.

Responsibilities

After completing an extensive internal training program at our office in Arnhem, you will:

Independently execute audits and processes;

Be responsible for the assessment of technical files and the auditing of quality systems of your customers (from high innovative start-ups to large multinationals, both national and international);

Act as a linking pin (account manager) and maintain frequent contact with customers, colleagues, external experts such as physicians, contractors and authorities;

Have the opportunity to represent DEKRA at conferences;

Travel within and outside Europe, approximately 20-30% of the time.

Your profile

A Bacherlor's or University level degree in life- and/or engineering sciences is a must;

A minimum of 4 years of full-time work experience in the medical device industry, including at least 2 years in Research & Development or Quality Assurance/Regulatory Affairs;

Experience in at least one of the following devices categories and areas of expertise: Active medical devices, Active implantable medical devices, Soft tissue implant, Cardiovascular devices, Drug device combinations or Animal tissue;

Experienced with quality management systems and relevant laws and regulations, at least CE;

Project management and auditing experience is considered an advantage;

English language skills are a must;

You are preferably already live in the Netherlands or are willing to relocate to the Netherlands.

Here is what we offer

• Competitive salary and comprehensive benefits;
• A variable performancebonus scheme;
• 25 vacation daysand13 ADV (Additional Days Off)for ample relaxation;
• Travel and remote work allowances;
• Discount on various insurance plans;
• Abundant opportunities forcareer growth, supported by multiple training programs;
• Engage in a challenging role within a cohesive team of proficient experts in a dynamic and international setting.

More about DEKRA

DEKRA is the world's largest non-listed expert organization in testing, inspecting, and certifying according to international safety and sustainability standards. Founded in Germany in 1925, the company's mission was to inspect vehicles to ensure traffic safety. Today, we offer a wide range of services, from product safety testing, audits, and inspections to damage assessment and HSE consulting. We operate in over 60 countries to ensure safety on the road, at home, and in the workplace worldwide. Explore all our services here . We have a clear mission: as a leader in testing, certification and inspection, we ensure that products, assets, and technologies are safe, reliable, and sustainable – building trust between people and technology. And you are welcome to join! Discover more about DEKRA here .

Questions?

Please note: We manage our recruitment and selection entirely in-house. We do not appreciate acquisition by agencies or intermediaries. Submitting candidates without prior consultation and an explicit, written assignment from DEKRA does not establish any rights. Unsolicited profiles will be considered unrequested and will not be processed.