Senior RA Program Manager

1 month ago

Limerick, Ireland BD Medical Full time

Job Description Summary The function of this role is to combine knowledge of scientific, regulatory, and business to drive projects forward based on the overall global regulatory strategy to executable plans and the coordination of cross-functional team efforts. The individual will serve as the primary project management point of contact and partner with the Consumables and Infusion System RA teams to ensure Regulatory functional plans are aligned with the IPD program objectives and commitments. The individual will work closely with other key cross-functional partners such as R&D, Commercial Marketing, Quality, Medical Affairs and Operations. Job Description We are the makers of possible 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. Become a maker of possible with us Our vision for Regulatory Affairs at BD The Regulatory Affairs team is helping to ensure speed to market for BD's innovative medical technologies by having an acutely patient-centric mindset. Main responsibilities will include: Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration. Provide strong operational leadership to Regulatory and program teams, providing scenario and visualisation support driving rapid and informed decision making, challenging status quo and fostering impactful innovation 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 Ensure coordination of critical regulatory information and team communications to ensure timely and accurate dissemination of the regulatory strategy and operational status throughout the team including co-development partners and/or other external partners, as required. Drive process improvements and embed best practices from across programs and functions into supported teams. Build value proposition through continuous refinement of delivery, prioritizing and focusing on areas of the highest impact and opportunity, and actively leading efforts to enable enhanced capabilities and impacts. Support and facilitate activity, resource and cost planning across the R&D project portfolio, as required. May attend to audits performed by internal and external authorities to represent RA positions and processes. Drive regulatory affairs procedural updates, as needed, in collaboration with cross functional inputs. About you Degree or equivalent in engineering or scientific discipline, or equivalent proven experience. Minimum of 5-7 years of experience in Medical Device Regulatory Affairs. Project Management experience required and knowledge of the regulatory framework pertaining to Medical Devices such as the MDD/MDR CE Marking Knowledge of and experience in pre-market regulations including regulatory and risk management processes. Good working knowledge of Design Control, Software Life Cycle, Risk Management, V&V processes Solid knowledge and material experience in international registrations/approval process for medical devices Strong knowledge in international standards and regulations including IEC 60601-1, IEC62304, IEC 62366 preferred. Click on apply if this sounds like you Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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