Regulatory Affairs Specialist

Are you a communicative person with excellent project management skills who would like to gain experience in regulatory affairs? Then, this position as a Regulatory Affairs Assistant might be interesting for you! In this role, you will ensure compliance with local regulatory requirements, the national and international guidelines, and the company policies for an internal project.

Apply Back to overview

What will your job be

As a Regulatory Affairs Assistant it is your responsibility to ensure compliance with local regulatory requirements, the national and international guidelines, and the company policies for an internal project within the Regulatory Affairs department. Therefore, you will have to collaborate with Manufacturers, Authorized Representatives and Global Teams. Your key responsibilities will be to:

  • Ensure regulatory compliance of Medical Devices (MD) for their access to the market of Belgium, Netherlands and Luxembourg
  • Identify Regulatory Issues & strategies concerning MD, report them to the relevant RA Leaders (at global and local level) and investigate/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 matters 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

What are we looking for

For the position as a Regulatory Affairs Assistant we are looking for an analytical and self-motivated candidate with excellent project management skills who enjoys doing problem-solving. Furthermore:

  • You ave a BSc (hbo) or MSc degree in life science, medicine, pharmacy or comparable field
  • You have project management experience
  • Fluent Dutch language skills are required
  • Previous experience in a Medical Devices or Pharmaceutical Company is preferred
  • Furthermore, you have excellent communication skills giving you the ability to build partnerships internally and externally
  • Besides you are able to analyze, interpret and synthesize regulation and guidelines

What do we offer

  • Secondment via CheckMark Labrecruitment for 6 months
  • Salary indication from €3000,- based on fulltime
  • Fulltime employement (40 hours/week), 32 hours/week can be discussed for strong contenders

Where will you work

A global biotech company that focuses on the development, pro¬duction and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases.

More information

Jurjen Wilschut
088 00 21 122
Ref.nr: 6610

Apply for Regulatory Affairs Specialist




The password must be at least 8 characters and contain at least 3 of the following: a capital letter, a lowercase letter, a number, a special character (!@#$%^&*()[]{}-_=+<>|)
The passwords do not match
Specify the job alert