Regulatory Affairs Specialist

4 weeks ago

London, Greater London, United Kingdom Becton, Dickinson and Company Full time
Job Title: Regulatory Affairs Specialist

Job Summary:
BD is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and standards for medical devices. This role requires a strong understanding of the regulatory framework, including the MDD/MDR CE Marking, and the ability to apply this knowledge to enable product development, manufacture, and life cycle maintenance.

Key Responsibilities:
  • Lead RA representative for design change assessment projects for active medical devices, responsible for assessing regulatory impact of the change - determining testing needs/documentation needs/registration needs.
  • Participate in the review of process/product changes, labelling, claims, product complaints, A&Ps (Advertising & Promotional materials), etc., to determine the need for any regulatory activities and to ensure compliance to International requirements.
  • Prepare and maintain regulatory files such as STED and EU MDD/MDR Technical Files.
  • Participate in cross-functional product development teams as the regulatory representative, development of regulatory strategies.
  • Work with BD processes and cross-functional teams to assess changes in standards/regulations and help determine their impact to Business.
  • Prepare regulatory dossiers for submission to Health Authorities and maintains them along the whole product life-cycle.
  • Drive Regulatory Affairs procedural updates, as needed, in collaboration with cross-functional inputs.
About You:
  • To be successful in this role, you will have proven regulatory affairs experience within the medical technology industry.
  • Minimum of a Bachelor's degree in scientific or engineering discipline.
  • Solid knowledge of the regulatory framework pertaining to Medical Devices such as the MDD/MDR CE Marking.
  • Solid understanding of Design Control, Software Life Cycle, Risk Management, V&V processes.
  • Solid knowledge and material experience in international registrations/approval process for medical devices.
  • You should be an enthusiastic teammate, able to participate with ownership in a complex and fast-evolving environment.
About BD:
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

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