Regulatory Affairs Specialist

Location
Friesland, Netherlands, Leeuwarden
Salary
Negotiable
Posted
13 Apr 2021
Closes
11 May 2021
Ref
282316
Contact
Gilson Heitinga
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Ra Specialist - well known Medical Device company

My client is looking for a Regulatory affairs Specialist to join their team of 4 other specialists. The company itself is well known in the medical device industry with a good reputation on the international market. This will be a great addition on your CV and will certainly provide career opportunities as you progress on the job market.

Benefits: Be part of a great dynamic team of specialists and work on innovative Medical Device products which will give you sense of pride and purpose. Enjoy the great open company culture and communicate with your management and peers who will give you a second opinion and value yours.

This will be an international role with European responsibilities and interesting collaborations with teams in different countries.

Therefore each day will be exciting and end with you gaining new knowledge from different points of view.

You will be able to balance your work-life even better with the possibility to work 1 or 2 days from home. This will mean less time in traffic, and more time for family, friends and hobbies.

You will:

  • Become an expert in your field
  • Be a point of reference within the company
  • Learn various perspectives from different cultures
  • Save time when not commuting between home and work

Responsibilities:

  • Work with applicable regulatory agencies and international consulates.
  • Assist in the preparation of the Technical File for CE marking in accordance with applicable laws and regulations and checklists for other countries such as Australia and Singapore.
  • Coordination and collection of specific registration information with R&D, Manufacturing, QA, and applicable departments, as vital to support registration requirements.
  • Advise in the interpretation and application of IVD regulations as well as the planning and implementation of new and updated regulations.

Requirements:

  • Minimum of 2 years experience in RA for medical devices or diagnostic industry (experience in the pharma industry is okay as well)
  • Knowledge of MDR or IVDR is a plus
  • Experienced in working in EU region
  • Fluent in English

If this job appeals to you please apply here or on the NonStop Consulting website or send it to me, Gilson Heitinga, on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.