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Regulatory Affairs Officer

As a RA Officer you see the big picture, recognize underlying trends, patterns or connections between apparently unrelated situations. You enjoy being part of a dynamic and fast-growing Dutch biotechnology company with ambitious people whose common mission is to help 200 million people worldwide with skin problems.

Bedrijfsnaam

Our client is a Dutch biotechnology company

Locatie

Omgeving Utrecht

Functie omschrijving

As RA Officer your main responsibilities will be to:

  • Maintenance and update of technical documentation during the product’s life-cycle according to of the Medical Device Regulation 2017/745 (MDR)
  • Assisting in the development of regulatory compliant procedures:
    • Providing regulatory assistance in compliance with requirements of the MDR identification and remediation of gaps
    • Interpret regulatory rules and provide assistance in communicating the changes through policies and procedures in collaboration with Quality Assurance department
    • Independent in performing research regarding updates in Medical Device related regulatory requirements
  • Contributing in setting up and implementing processes in line with the MDR and ISO 13485 to safeguard the safety of the Medical Devices (tools QMS and SOP’s)

Profiel kandidaat

As a real team player you are enthusiastic, proactive and you contribute towards team goal by working co-operatively with others, also gets people's input to decisions/plans, and promotes team spirit. With your strategic orientation you see the big picture, recognize underlying trends, patterns or connections between apparently unrelated situations.

You also meet the following requirements:

  • Preferably Bachelor, Master or PhD diploma in biological/pharmaceutical sciences or equivalent
  • 1 to 2 years of relevant work experience

Bedrijfsprofiel

Our client is a Dutch biotechnology company, a pioneer and market leader in the development of specific, targeted antibacterial products, intended to become an alternative to antibiotics. It produces skin products that can help millions of people around the world in addressing their skin problems. Our client is a people-oriented company and develops and produces its own products in the Netherlands on the basis of thorough knowledge of customers' problems.

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