Magnet.me  -  Het slimme netwerk waarop hbo‑ en wo‑studenten hun baan of stage vinden.

Het slimme netwerk waarop hbo‑ en wo‑studenten hun baan of stage vinden.

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Internal Clinical Expert Medical Devices

Geplaatst 22 mrt. 2024
Werkervaring
1 tot 3 jaar
Full-time / part-time
Full-time
Soort opleiding
Taalvereiste
Nederlands (Vloeiend)

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Do you want to add your clinical research experience to another world besides medical care? Do you have an interest in being at the forefront of safely releasing the newest active medical equipment for patient care to the European Market? Are you a Medical Doctor with clinical research experience and affinity with technology and medical equipment? Do you want to work one day or more in a week within our certification organization? Do you want to investigate the clinical evaluations of medical device manufacturers within Europe and to work together with clinical practitioners from leading hospitals, in order to safeguard patient safety? Do you want to further build on your knowledge and experience in an ambitious international Notified Body organization? Then you might well be Kiwa’s new Internal Clinical Expert for Medical Device certification.

About the role

To certify diagnostic and therapeutic medical devices, the role of clinicians is vital to guarantee the safety and performance before these devices are released for treatment of patients. Kiwa certifies medical devices and software according to the European Medical Device Regulation (MDR).

In this role you will review the clinical evaluations and applications of manufacturers and inspect results from post-market clinical follow-ups, as part of a MDR-certification procedure.

Further you will:

  • Maintain the clinical/medical oversight during the complete conformity assessment;
  • Identify when specialist input is required for the assessment of the clinical evaluation and identify qualified experts;
  • Guide product reviewers and external clinical experts in the assessment of the clinical evaluation;
  • Review and scientifically challenge the clinical data, the clinical evaluation and the review of the external experts;
  • Make an assessment of the manufacturer's clinical evaluation and a clinical judgement of the opinion provided by external experts.

You will work next to a Senior Internal Clinical Expert. After a training program you will be qualified to perform the Internal Clinical Expert tasks independently.

Do you have what it takes?

You want to take a new step in your career and are interested to further develop your knowledge and skills in a new working area. You are ready to receive an internal training program to become qualified as Internal Clinical Expert. You get energy from contributing to the safety and performance of medical devices. You can work independently as well as in a team and take ownership for your work. You have good communication skills, informing and reporting to stakeholders in a clear and timely manner.

For this position, we’d like you to bring these educational and personal skills:

  • University level educational background in Medicine, with specialisation in, for example Anaesthesiology, Surgery, Intensive care of Internal Medicine;
  • Affinity with medical equipment;
  • Experience with clinical investigations and clinical literature reviews;
  • Knowledge of risk management in a clinical context;
  • You are preferably based in The Netherlands and allowed to work here;
  • You are available for 8 to 32 hours per week;
  • Auditing experience is considered an advantage;
  • Presentation and organisation skills to organise and conduct assessments.

What can you expect from us in return?

As an Internal Clinical Expert at Kiwa, you’ll hold a challenging position in a technically oriented, ambitious, expanding international organisation. At Kiwa, we value your professional development and personal wellbeing.

Kiwa Dare is a Notified Body since 2015, that already received its MDR-designation in 2019. This means that almost all the work is targeted towards new clients under the MDR, leading to an intensive learning environment and ample possibilities to contribute to the development of our organization. When it comes to our terms and conditions, we offer you a salary tailored to your professional competence and experience and the possibility to work part-time.

Where you’ll work

In this role, you will work for Kiwa Dare, based in Woerden, The Netherlands. You will be part of the Medical Devices team: This is a small team with highly qualified and driven medical device professionals. You will work for and report to Gert Grooters, Team Leader of the Notified Body.

Kiwa behoort tot de wereldwijde top-20 van TIC (Testen, inspecteren en certificeren) bedrijven. Op het gebied van inspectie en certificatie bepalen we mede de norm. Maatschappelijke verantwoordelijkheid nemen we daarin heel serieus. We werken met z’n allen hard om de wereld elke dag duurzamer en veiliger te maken. Kiwa speelt continu in op veranderingen in de markt, dat is wat…


Kiwa behoort tot de wereldwijde top-20 van TIC (Testen, inspecteren en certificeren) bedrijven. Op het gebied van inspectie en certificatie bepalen we mede de norm. Maatschappelijke verantwoordelijkheid nemen we daarin heel serieus. We werken met z’n allen hard om de wereld elke dag duurzamer en veiliger te maken. Kiwa speelt continu in op veranderingen in de markt, dat is wat ons werk uitdagend en afwisselend maakt. We zijn een dynamische organisatie waarin je alle ruimte hebt om te ontwikkelen zodat je alles uit jezelf kunt halen.

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