Regulatory Affairs Specialist
Vacature van BD Kiestra
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.
- 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.
- 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!