Regulatory Affairs professional

Becton Dickinson
11 Jan 2018
10 Feb 2018
Contract Type
Full Time
Regulatory Affairs professional

Location: Winnersh, UK

Fix term contract - 12 months

We are seeking a Regulatory Affairs professional with at least 3 years' experience who would like to work in a communicative, international environment at Becton Dickinson.

As a Regulatory Affairs Specialist reporting to our RA Manager you'll be responsible for preparing, obtaining and submitting country specific registration documentation to support the name change from CareFusion to Becton Dickinson, and Company.

Playing a major role in RA you'll deploy your talents in coordinating additional project changes and combining registration activities where applicable as well as support the updating of Technical Files.

You will be creating and maintaining registration database and provide weekly accomplishments to the RA manager and project team.

Your key responsibilities will also include: Reviewing and/or researching country-specific requirements for registration purposes Helping to establish and maintain an information network for purposes of monitoring registration activities and the coordination of implementation of the BD labelling into manufacturing. Preparing regulatory documentation / dossiers for submission to Health Authorities of regulatory files such as STED and Technical Documentation (if applicable)

Ideally educated to Bsc or Msc level in a related field you'll have a proven track record in regulatory affairs, preferably working at a medical device or pharma company for at least 3 years, but certainly with a demonstrable ability of good communicational and coordination skills with high attention to details. Happy working autonomously and generating, prioritising and handling your own work, you've got the skills to work in a team as well.

You'll also bring:

A sound knowledge of Medical Device CE Marking Directive 93/42/EEC (and its amendments)

Experience in worldwide registrations Excellency in Excel and Word

A BA/BS degree is required. Preferred education/experience areas include health care, physical, biological, and regulatory sciences, clinical, engineering, potentially coupled with advanced degrees (MS, MBA, PhD, etc.)

With Sound knowledge of Medical Device CE Marking Directive 93/42/EEC (and its amendments);

Interested in a career with BD, but this position doesn't fit your skills and experience?

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