Medical Devices Expert & Auditor

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.

• 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.

• Competitive salary and comprehensive benefits;

• A variable performance bonus scheme;

• 25 vacation days and 13 ADV (Additional Days Off) for ample relaxation;

• Travel and remote work allowances;

• Discount on various insurance plans;

• Abundant opportunities for career 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?

Do you have any questions about this vacancy? Please contact Jaimie Houtters. You can reach her at +31 6 29 65 86 96 or by email to recruitment.nl@dekra.com.