Regulatory Affairs Specialist - Utrecht

Vacancy information

Publication date:December 16 2020
Employment type: Permanent
Sector: Medical Devices
Function Group: Quality/RA

Function Group: Quality/RA / QA Engineer

Organization

For a rapidly growing scale-up active in the medical devices industry, we are looking for a Regulatory Affairs Specialist with experience within the medical devices industry (ISO:13485). The organisation develops and produces innovative and life changing electronic medical devices with the goal to give people more time to enjoy life, and they want to be a company, where people can rely on. Currently, the organisation experiences tremendous growth, and is expected to become a global leader in the near future. At the moment, about 100 employees work at the organisation, which mainly consist of talented and ambitious professionals, who believe in a ‘work hard, play hard’ approach. You will be part of the quality department which now consists of 15 employees and report directly to the Senior Regulatory Affairs Manager.

Function

As a Regulatory Affairs Specialist, you will have a focus on leading the transition from MDD to EU MDR and making the company compliant with the new regulations. On a daily basis, you will be responsible for writing and optimising technical files, verification of the compliance and effectiveness on processes regarding the EU MDR and review clinical & post market clinical investigations. In this role, knowledge of the EU MDR is important and you will support colleagues by giving training and lead audits to verify the effectiveness of the overal implementation of the regulations.

Requirements

The organisation is looking for someone who, ideally, has the following profile:

  • A bachelor degree related to regulatory/quality, mechanical or health sciences
  • A minimum of 5 years experience within the medical devices industry is a must (ISO:13485)
  • Experience in post market surveillance and audits.
  • Experience in implementing EU MDR regulations
  • Ambitious and hard working mentality
  • Proactive and service mindset to deliver the highest possible quality
  • European work permit
  • Fluency in English

Offer

The organisation can offer you the following:

  • Market competitive salary
  • Legal number of vacation days plus the eight Dutch national holidays (32 total)
  • 1 year contract
  • A bonus
  • Defined benefit pension scheme and disability insurance
  • 40 hours per week to be worked anytime between 07:00 to 19:00
  • Team lunches and events outside of working hours
  • Informal dress code

Application

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

Quintes Hamer
Associate Medical Devices

+31(0)6-82100758
+31(0)23-7548660
q.hamer@qtcrecruitment.com

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