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  • Location

    Amersfoort, Netherlands

  • Job title:

    Regulatory Affairs Assistant

  • Sector:

  • Job ref:

    43936

  • Startdate:

    2020-06-01

The Company 
Caring for the world, one person at a time has inspired and united the people of this company for over 130 years. They embrace research and science, bringing innovative ideas, products and services to advance the health and well-being of people. Employees of this company work with partners in health care to touch the lives of over a billion people every day, throughout the world.
They are one of the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets

Role Description 
Ensuring compliance with local regulatory requirements, the national and international guidelines and the company policies under the Direction of local Regulatory Affairs Lead with regards to the related project.
Collaborate with Manufacturers, Authorized Representatives and Global Teams, regarding Dutch and Belgian legislation and related requirements.

Responsibilities 

  • Label and Instruction for Use – review and approval, and the management thereof.
  • Update of Regulatory Affairs database.
  • Local Management of the Project and related communication to all stakeholders.
  • Ensure regulatory compliance of Medical Devices for their access to the market of Belgium, Netherlands and Luxembourg.
  • Identify Regulatory Issues & strategies concerning Medical Devices, in the scope of the Project, report them to the relevant Regulatory Affairs Leaders (at global and local level), investigate and suggest solutions to resolve them.

Requirements

  • Bachelor's or Master's Degree in a relevant discipline (Pharmacy, Engineering, Biology, Chemistry e.g.
  • Native Dutch and fluent English
  • Advanced Excel experience
  • Preferred to have a background in a highly regulated environment
  • Knowledge of EU Medical Device requirements are beneficial
Do you want to know more or apply for this vacancy? Upload your CV via the apply button below!

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