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Senior Regulatory Affairs Specialist - Amsterdam

Function Group: Quality/RA / RA Manager

Organization

For an innovative international Medical Device company we are looking for a Senior Regulatory Affairs Specialist. This company contributes to the health and well-being of people all over the world through the advancement of science and the discovery of new technologies.

Function

Within this position you will confirm the regulatory compliance of products introduced to the European market. You will preform the obligations as a point of contact with the European Committee for post-market surveillance and vigilance, will cooperate with people involved in the post-market surveillance under the IVDR and work closely with Regulatory Affairs and Quality Team in Japan to establish the robust Regulatory/Quality system that comply with IVDR. You will provide Product Development Teams with guidance and interpretation of IVDR requirements for the design and development of new products and assist and cooperate the product performance evaluation or clinical trail in Europe.

Requirements

  • Bachelors/Masters Degree or equivalent combination of qualifications in chemistry, biology or other related fields;
  • Minimum of three years of experience in European In Vitro Diagnostic Directive (IVDD) for Class A, B and Class C products such as laboratory and Point of Care IVD instrument and reagent, preferably experience with Class D products;
  • Proven experience with ISO, GMP/QSR and other regulatory issues related to Medical Devices;
  • Minimum of three years experience in Regulatory Affairs or Quality Systems for medical products manufacturing;
  • Proven proactive managerial, team-based skills;
  • English business level or above.

Offer

This organisation does the utmost best to create an excellent and welcoming working environment. Furthermore, the company offers the following:

  • Competitive salary
  • Secondary package

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Lettie Steur
Senior Associate | Regulatory Affairs | Medical Devices

+31(0)23-7548660
+31(0)6-30154340
l.steur@qtcrecruitment.com

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