BD (Becton, Dickinson and Company) EU Regulatory Affairs Specialist in Winnersh, United Kingdom
Job Description Summary
Remote location with occasional travel to the Winnersh Office
Competitive Salary + package
A fantastic opportunity has arisen for an EU Regulatory Affairs Specialist to join our Regulatory Affairs team focusing on our Infection Prevention portfolio.
Healthcare-associated infections (HAIs) represent a large and growing problem for our healthcare system. BD is uniquely positioned to help hospitals improve safety and reduce cost through our systematic and targeted approach, which combines clinically proven products, HAI surveillance and continuing education to help clinicians reduce the risk of infection.
Remote Home-based opportunity
As EU Regulatory Affairs Specialist you will register and maintain pharma and combination product licenses in the EU region in a professional, compliant and timely manner, and ensure that the products sold in the countries covered by the Infection Prevention business meet regulatory requirements.
Key Responsibilities include:
Liaise with the Infection Prevention team, including regional office, marketing/sales organization or local distributors, international RA, US manufacturing and R&D, to ensure that the existing regulatory requirements are known and controlled.
Provide timely support when requested by these organizations in preparing necessary registration documents, supporting timely submissions and maintaining an adequate archiving system.
Coordinate the creation of registration files to be submitted in the targeted markets for the Infection Prevention portfolio.
Proactively follow-up on products registrations and ensuring that post-market obligations are met in the European region.
Provide regulatory assessments on change control / design control documentation to ensure regulatory compliance.
Manage LCM activities to update and maintain the regulatory files of the infection prevention portfolio in the EU region
Maintain the database in which all registrations made in these territories with be documented.
Report to the local management on the performances of the Regulatory process system, including any needs for improvement.
Monitor the regulatory environment and communicate any potential impact to the infection prevention business to key stakeholders.
Optimize and maintain RA processes related to the Infection Prevention Regulatory Affairs European team
Review of promotional materials for the UK market
Within this role there would be the opportunity to develop into medical devices regulation.
To be successful in this role you will have a life sciences degree (pharmacy/chemistry/biology) with a minimum of 3 years experience in Regulatory Affairs in a healthcare or pharmaceutical - regulated environment or equivalent experience. You will ideally have European experience, however candidates from purely a UK background will be considered.
You will have excellent written and oral English skills and have the ability to analyse Regulatory documents. You will be comfortable reading professional journals, technical procedures or government regulations and will have the ability to write reports, registration modules and procedure manuals. You will be an effective presenter with the ability to respond to questions from a broad range of internal and external partners and have strong reasoning skills.
The successful candidate must be comfortable to travel up to 10% of the time.
We are happy to consider candidates working remotely who are physically based in the UK or France.
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Primary Work Location
GBR Winnersh - Eskdale Road
BEL Erembodegem - Dorp 86, FRA Le Pont-de-Claix Cedex, POL Wroclaw - Legnicka
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.