Regulatory Affairs Specialist

3 weeks ago

London, Greater London, United Kingdom Becton, Dickinson and Company Full time
Job Description

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Becton, Dickinson and Company. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.

About the Role

  1. Lead the assessment of regulatory impact of design changes for active medical devices, ensuring compliance with international requirements.
  2. Participate in the review of process/product changes, labeling, claims, and product complaints to determine the need for regulatory activities.
  3. Prepare and maintain regulatory files, including STED and EU MDD/MDR Technical Files.
  4. Collaborate with cross-functional teams to develop regulatory strategies and assess changes in standards and regulations.
  5. Prepare regulatory dossiers for submission to Health Authorities and maintain them throughout the product life-cycle.
  6. Drive Regulatory Affairs procedural updates, as needed, in collaboration with cross-functional inputs.

Requirements

  1. Proven regulatory affairs experience within the medical technology industry.
  2. Minimum of a Bachelor's degree in a scientific or engineering discipline.
  3. Solid knowledge of the regulatory framework pertaining to Medical Devices, including MDD/MDR CE Marking.
  4. Understanding of Design Control, Software Life Cycle, Risk Management, and V&V processes.
  5. Solid knowledge and material experience in international registrations/approval process for medical devices.

About Us

Becton, Dickinson and Company is a leading global medical technology company that advances the world of health. We are committed to fostering an inclusive, growth-centered, and rewarding culture that empowers our employees to make a meaningful impact.

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