BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Drachten, Netherlands
Job Description Summary
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 !
Primary Work Location
NLD Drachten - Marconilaan
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.