Internal Clinician

DEKRA Medical is a global leader in the certification of medical devices including in-vitro diagnostic (IVD) devices. Operating through two Notified Bodies and one UK Approved Body we serve customers across six regions. At DEKRA Medical we are more than a regulatory checkpoint we are a trusted strategic partner for medical device manufacturers. With a deep-rooted commitment to navigating complex regulatory frameworks especially within the high-risk and innovative medical device sectors we empower our clients to achieve market access and maintain a competitive edge.

What you will do

Join DEKRA and help ensure innovative high-risk medical devices meet the clinical standards under the EU Medical Device Regulation (MDR). Your expertise will directly impact patient safety and the future of healthcare technology.

If youre an academic healthcare professional with clinical practice experience and you have the motivation to work with an enthusiastic team ensuring that safe products are brought to market then this is the position for you!
Your clinical experience is essential here but youll also receive extensive training on the legal aspects. The questions to be answered include: Do any risks to the patient indeed outweigh the products benefits Have all the clinically-relevant aspects been investigated sufficiently by the manufacturer Are alternative products available that pose less risk with similar results Your clinical background will enable you to answer some questions yourself but we often also enlist the help of clinical experts from the field.

How does you day look like

In the morning you discuss all aspects of an innovative neurostimulator with one of our more technically-oriented (life-science) colleagues. Then you have consultations on some complicated medico-scientific issues with the clinical team. After lunch you start to train one of our external clinical experts to ensure he or she is up to date with the current regulations and the processes to be followed. You ends your day with a Teams meeting with another external expert to discuss a new type of stent.
Combining this position with a part-time job in the clinic is certainly an option given that some of the work can be scheduled flexibly. To ensure quality we want as diverse a team as possible with different specialist knowledge. For example a background as: internist neurologist cardiologist surgeon MDL doctor neurosurgeon plastic surgeon cardiothoracic surgeon ophthalmologist dermatologist urologist gynaecologist (interventional) radiologist paediatrician clinical physicist or clinical technologist.

• Review clinical data on medical devices critically;

• Recruit train and supervise external clinical experts;

• Assess and augment the quality of clinical experts reviews critically.

What we expect from you

• Physician clinical technologist or clinical physicist with at least two years working experience in patient care;

• Medical specialty in cardiothoracic vascular general surgery or gastrointestinal is an advantage.

• Experience in clinical research conducting or reviewing (pre-)clinical studies and knowledge of medical statistics;

• Work experience in another Notified Bodies or MDR-related clinical evaluation review is an advantage.

• BIG Dutch professional healthcare registration is an advantage; absence of this is negotiable if you have sufficient work experience;

• Decisive and result driven able to apply regulatory requirements to a broad set of clinical device use cases.

• Meticulous fast learner.

• Apart from clinical also a strong interest in technical and regulatory aspects of devices.

• Collaborate with technical and clinical colleagues.

• Ability to clearly explain decisions made based on regulatory and clinical background.

• Ability to handle multiple projects without losing oversight focus and priorities.

• Enjoy dealing with customers presenting DEKRA at events webinars etc.

• Good communication skills in English;

• Available for 16 40 hours per week;

• Willing to work at least one day per week in Arnhem (remote options available).

• 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.

Curious about your colleagues Discover here what they say about working at DEKRA.

More about DEKRA

DEKRA is the worlds largest non-listed expert organization in testing inspecting and certifying according to international safety and sustainability standards. Founded in Germany in 1925 the companys 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 or by email to.

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.