Regulatory Affairs Specialist

Vacature van BD Kiestra

  • BD Kiestra
  • Drachten
  • HBO
  • 1 jaar

Innovatie Regulatory IVD

Are you passionate about Regulatory Affairs? Do you love working in a dynamic environment? Then, this is the job for you! We are looking for an experienced regulatory specialist to support our team at BD Kiestra in Drachten, Netherlands.

As a Regulatory Affairs Specialist, you will support BD in regulatory activities for new product development, acquiring international registrations, and post-approval maintenance of the international registrations.

Your responsibilities:

  • You will support the preparation of global regulatory submissions such as but not limited to clinical trial application, initial registrations, changes/variations, and renewals by:
    • Coordination of timely preparation of requests for Free Sale Certificates.
    • Work with applicable regulatory agencies and international consulates.
    • Coordination and collection of specific registration information with R&D, Manufacturing, QA, and applicable departments, as vital to support registration requirements.
    • Collaborate with OEM’s to collect registration information.
    • Assemble technical information to build a ‘clinical report’ or a ‘dossier’.
    • Assist in the preparation of the Technical File for CE marking in accordance with applicable laws and regulations and checklists for other countries such as Australia and Singapore.
    • Assemble/assist with 510(k) submission and acquire/support clearance in the U.S.
  • Participate in the review and approval of labelling and promotional materials.
  • Participate in New Product Development Core Teams and provide regulatory input in these teams including but not limited to the preparation of Regulatory Strategies.
  • Maintain departmental procedures (SOP’s and work instructions).
  • Maintain accurate and complete regulatory files and applicable records.
  • Advise in the interpretation and application of IVD regulations as well as the planning and implementation of new and updated regulations.

Your Profile:

  • You have a minimal 3 years of demonstrated ability in regulatory affairs, ideally in the in Vitro diagnostics area or alternatively in the Medical Device industry.
  • You have a bachelor’s degree in a technical or scientific field in health-care, clinical, engineering, physical, biological, or regulatory sciences, potentially coupled with advanced degrees.
  • You have new product development experience, preferably in a global IVD or medical devices company. International registration experience is a plus!
  • You have knowledge and understanding of EU and worldwide registration and regulatory requirements.
  • You have knowledge of ISO 13485, 21 CFR 820, and new product development (plus)!
  • You have strong writing skills (in English and Dutch) and the ability to use appropriate software tools to develop and edit documents for registration purposes.
  • You can lead and monitor multiple registrations/projects simultaneously.
  • You have strong interpersonal and analytical thinking skills and are able to multitask and meet deadlines.
  • You have a high level of integrity, initiative, self-motivation, and energy.
  • You have an eye for detail, this is critical.

What can we offer you?

We can offer you a phenomenal possibility to work in an international company (first-in-class in its business area). We offer opportunities for professional and personal growth in a challenging and rewarding work environment within dynamic, diverse, and international teams.

Are you interested? Please Apply!

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