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RA Specialist

Regulatory Affairs Specialist

For an international client operating in the in vitro diagnostics, I am looking for a Regulatory Affairs Specialist. In this role, you will be solely responsible for regulatory affairs at the location in the Netherlands. This company is currently in the IVDR transition period and is looking for expertise to ensure compliance. You will report to the QA/RA Manager and be part of the QA/QC/RA team. This position is located in the region of Amsterdam.

Tasks/responsibilities

  • You will act as the RA representative to Notified Bodies and regulators
  • You will prepare and coordinate registration, submissions and technical documentation. This includes writing and maintaining files
  • You will review and approve promotional materials and labelling
  • To ensure compliance with the IVDR, you will actively manage revision of the technical documentation. Furthermore, you will manage the IVDR implementation plan by implementing actions, updating and developing the plan
  • Provide regulatory support to product development projects to ensure compliance with regulations
  • Report product changes to regulatory authorities in a timely and adequate manner
  • If adverse events occur, you will ensure timely and compliant reporting
  • You collaborate with Product Management and the global regulatory team to coordinate the development of regulatory strategies
  • Supporting multiple audits (for instance from Notified Bodies and MDSAP audits)

Requirements

  • Bachelor degree (scientific, medical or technical background
  • Minimum of 3 years RA experience with IVD or medical devices (IVD experience is a big plus)
  • You must have knowledge of IVD and/or medical device regulations from the EU and the USA. Regulations from other regions (such as Asia and South America) is desirable
  • RAC is preferred
  • Excellent command of English is required; Dutch is nice to have
  • You must be able to work independently
  • You are stress resistant

Offer
Besides a position with lots of responsibilities, this company offers the following:

  • Competitive salary (based on knowledge and experience)
  • Bonus
  • Non-contributory pension
  • Travel allowance
  • Growth opportunities
  • Training

Interested in this position?
Are you the Regulatory Affairs Specialist I am looking for? Please do not hesitate to contact Joey Wielkens on the phone number 020-5221577 or send an e-mail to j.wielkens @ realstaffing.com. You may also contact me if you have questions about this role.