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Regulatory Affairs Manager - Groningen

Function Group: Quality/RA / RA Manager

Organization

An innovative medical device company focused on cardiovasculair products is looking for an experienced Regulatory Affairs Manager to give guidance to a team of four Regulatory Specialists. You will be part of a smart, driven company that shares your passion for exploration and discovery. Within this company you will work in a dynamic environment in which you will have no shortage of responsibilities and sufficient space to develop yourself even more.

Function

In this exciting role you will provide the company of the needed Regulatory knowledge, guidance and advice. You will be the strategic manager of four Regulatory Specialists and will act as a entrepreneur by making new technical files and getting old files up to date with new MDR standards. You work as a key player in preparing and collecting regulatory submission deliverables for product registrations. You will coordinate the submissions effectively, organise meetings for further alignments with the various stakeholders, and ensure the implementation of country specifics regulatory projects.

Requirements

Job requirements:

  • A bachelor or master degree in life sciences/medical field
  • Proven experience in managing positions within European Regulatory Affairs within medical device or IVD industry
  • Solid Technical knowledge of EU IVD Directive and IVD Regulation or equivalent in Medical Devices Directive/Regulation
  • Excellent written en verbal communication skills in Dutch & English
  • A creative entrepreneurial mindset

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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