Regulatory Affairs Specialist

Locatie: Amersfoort, Utrecht, Nederland
Salaris: competitive
Sectoren: Regulatory Affairs
Soort functie: Freelance
Solliciteren

One of our clients is looking for a Regulatory Affairs Specialist for 40hours a week in Amersfoort, beginning as soon as possible.

Regulatory Affairs Specialist

Project

Ensure compliance with local regulatory requirements, the national and international guidelines and our 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

  • Ensure regulatory compliance of Medical Devices (MD) for their access to the market of Belgium, Netherlands and Luxembourg.
  • Identify Regulatory Issues & strategies concerning MD, in the scope of the Project, report them to the relevant RA Leaders (at global and local level), investigate and suggest solutions to resolve them.
  • Support for One MD Organizations in Netherlands and Belgium related to the Project.
  • 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.
  • Handle all necessary activities for the release of SKU (codes) restrictions
  • Collaborate with local Commercial, Marketing, Tendering, Finance & Supply Chain teams, to ensure flawless completion of the Project and related activities, and accurate and timely reply to stakeholder requests.

Details

  • Start date: ASAP
  • Duration: 10 months
  • Location: Amersfoort (The Netherlands)

Requirements

  • Project management
  • Ability to build partnerships internally and externally
  • Analytical and self-motivated person who enjoys doing problem-solving
  • Strong skills in working with Microsoft Excel and software applications/databases
  • Ability to analyse, interpret and synthesize regulation and guidelines
  • Ability to identify regulatory issues, risks and priorities, and manage them
  • Consistent skills to work in parallel environments (business and regulation), to provide feedback and background of regulation update and its impact on RA strategy.
  • Previous experience in a Medical Devices or Pharmaceutical Company beneficial

Apply now!

Are you the Regulatory Affairs Specialist that I'm looking for? Please contact Femke Fokkema via 020 522 1588 or f.fokkema[at]realstaffing.com

Solliciteren