BD (Becton, Dickinson and Company) Regulatory Affairs specialist EMA – BD Life Sciences in Erembodegem, Belgium
Job Description Summary
As RA Specialist you will focus on providing regulatory support for our BD Life Sciences products (IDS and BDB) in EMA, such as product registration or tender requirements, ensuring products are being registered in a timely manner. You will assess the impact of the EU regulations, EU IVDR, and EU MDR on the product registrations in the EMA countries and ensure that the local regulatory requirements are met to market the products.
Process regulatory amendments and re-registrations in relation to existing product registration for our BD Life Sciences products for the EMA regio.
Coordinate timely preparation of requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sales certificates, and Certificates of Exportability. Interfaces hereto with the applicable regulatory organizations within BD or regulatory agencies directly
Collaborate with OEM's to collect specific registration information as needed.
Assemble technical information to build a "dossier" as needed.
Maintain the EMA Registration databases
Review and respond to customer requests for regulatory documents
Follow up on all required translations for labels and IFUs
Develop and maintain procedures (SOP's and work instructions) for international product registrations and/or regulatory activities as needed
Obtain knowledge of EU regulatory requirements for in vitro diagnostic medical devices products and medical devices which may impact the BD Life Sciences Business in EMA
In addition, you propose and initiate continuous process improvements and manage small projects individually.
More about yourself:
You have a related degree and 1-2 years or more experience in a similar industry. Life sciences is a plus!
Industry/function-specific certification is preferred.
You are proficient in English, any additional EU language is nice to have.
You are structured and self-organized and people recognize you as a highly motivated self-starter.
You have an analytical and problem-solving mind with amazing organizational and planning skills.
You promote a collaborative environment and remove obstacles to teamwork across the organization
You love to work in an international environment and are open to travel up to 10%
What can you expect from us?
A varied function at a med-tech producer with an important social contribution.
An informal working atmosphere, multifaceted corporate culture, and an environment that lets you grow and develop.
A very attractive remuneration package!
Interested? Apply now!
To ensure the safety of our associates, BD supports remote work where possible. This position is based in the listed location, but is temporarily remote-based due to Covid-19. We are continuing to monitor the situation and follow local governmental guidance to advise when is the right time and safe for our associates to return to their BD work location.
Primary Work Location
BEL Erembodegem - Dorp 86
FRA Le Pont-de-Claix Cedex
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.