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  • Location

    Amersfoort, Netherlands

  • Job title:

    Regulatory Affairs Specialist

  • Sector:

    Medical Devices

  • Job ref:

    42884

JR. Regulatory Affairs Specialist 

Our client is one of the world's most important manufacturer of health care products, for the pharmaceutical, and medical devices and diagnostics markets.
In this role you will guarantee the compliance of Medical Devices with local regulatory requirements, the national and international guidelines.

Responsibilities:

• Ensure regulatory compliance of Medical Devices (MD) for their access to the market of Belgium, Netherlands and Luxembourg.
• Identify Regulatory Issues & strategies concerning MD and suggest solutions to resolve them.
• Provide regulatory support to ensure consistent collaboration with franchises and EMEA/ Regulatory Affairs, and act as the main contact person for any natters related to the Project impact issues.
• Collaborate with local Commercial, Marketing, Tendering, Finance & Supply Chain teams, to ensure completion of the Project.

Requirements:

• Languages: Fluent English (speak, write) and Dutch (speak and write)
• Strong skills in working with Microsoft Excel and software applications/databases
• Ability to analyze, interpret and synthesize regulation and guidelines
• Ability to identify regulatory issues, risks and priorities, and manage them
• Previous experience in a Medical Devices or Pharmaceutical Company beneficial


If this is something you are interested in, please contact me at d.cantore@sire-search.com or at +31 20 658 98 00.

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