Senior Regulatory Affairs Specialist - MMS (Hybrid)

The function of this role is to combine knowledge of scientific, regulatory, and business issues to enable product development, manufacture and life cycle maintenance to meet applicable regulatory requirements and applicable technical standards. The individual has to gain department and platform level influence by participating to all RA activities and sharing regulatory expertise to demonstrate compliance with changing global regulations, also identifying, preparing and collecting data needed to obtain and maintain certifications and commercialization authorizations of BD products.,

• Lead RA representative for design change assessment projects for active medical devices (PEMS), responsible for assessing regulatory impact of the change - determining testing needs/ documentation needs/ registration needs. Close liaison with supply chain/ regional regulatory folks etc. to ultimately implement the change in production.
• Lead and execute international product registrations attending to individual country specific requirements; monitor and report progress.
• Participate to 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.
• Provide assistance and support for audits performed by internal and external authorities to represent RA positions and processes.
• Works 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.
• Handle CAPAs to implement corrective and preventive actions.
• Drive Regulatory Affairs procedural updates, as needed, in collaboration with cross functional inputs.
• May support transition of products from MDD tech files to MDR technical documentation and any other business critical projects, as needed.
• May participate in gap assessments relating to international standards and regulations including IEC60601-1, IEC62304, IEC 62366 preferred.
  
  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
• Sound 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.
  
  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.
Why join us? A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.