**Job Description Summary** **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. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a **maker of possible** with us. **Summary:** Reporting to Medication Management Systems (MMS) Pharmacy Automation (PA) Regulatory Affairs Manager, the Senior Specialist, Regulatory Affairs provides regulatory expertise to MMS-PA platform. This individual conducts the regulatory affairs activities within the MMS-PA platform. He/she contributes to the development of MMS-RA strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs. Such assessments may influence the scientific or technical direction of product design and/or development in support of worldwide registrations. The Senior Specialist, Regulatory Affairs will ensure functional excellence in regulatory activities to achieve timely worldwide clearance, of MMS-PA products with desired claims. Additionally, this individual plays an active role in external industry group efforts to shape policies, guidance, and standards that are of strategic importance to MMS-PA. This individual will communicate new developments in worldwide regulations affecting MMS-PA products to MMS-PA stakeholders. **Job Responsibilities:** + Directs the premarket regulatory affairs activities within MMS-PA, which may include interactions between MMS-PA and Notified Body, as well as other government agencies as required + Contributes to the development of MMS-PA strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs + Ensures functional excellence in regulatory activities to achieve timely worldwide clearance/release of MMS-PA products with desired claims + Plays an active role in external industry group efforts to shape policies, guidance, and standards that are of strategic importance to MMS-PA + Communicates new developments in worldwide regulations affecting MMS-PA products to MMS-PA stakeholders + Coordinates and advises the preparation of EU Technical Files for CE mark (Machinery Directive/Regulation), and materials required for global registration of products + Represents the business in interactions and negotiations with regulatory agencies and notified bodies about premarket requirements, acceptable labeling claims, etc. + Provides a high degree of regulatory expertise and experience to MMS-PA’s new product development programs, serving as a Core Team advisor and champion for MMS-PA’s Global Product Development System (GPDS) + Serves as a regulatory expert for labeling and promotional materials review, experimental designs, and data analysis as they relate to registration and commercialization of PA products + Reviews product development protocols to assure collection of appropriate data for product release and regulatory compliance + Coordinates with Quality function on compliance activities and responses to quality audit findings + Drives improvements in capability, such as customer centricity, regulatory knowledge, project leadership skills, effective team participation and communication + Instills a culture of continuous improvement by identifying and implementing improvements to support and achieve functional excellence + Participates when needed in activities associated with Field Corrective Action (FCA) reviews by the FAC committee and supports regulatory and notified body inspections. This includes routine interaction with Quality and Regulatory Compliance personnel. **Qualifications:** + Experienced knowledge in US and global electrical equipment regulations, and software a plus + Demonstrated ability to perform critical thinking at a high level of proficiency, to exercise independent judgement and discretion within a broadly defined range of policies and practices. + Demonstrated ability to deliver desired outcomes via innovative ideas and approaches. + Demonstrated business acumen and critical thinking skills. + Excellent communication (oral/written) and negotiation skills. + Independently leads multiple long-term projects and/or complex projects without direct supervision. + Demonstrated prioritization, organizational and planning skills, including committed, focused urgency and working towards results to meet business strategies and needs. Orientation for detail work product, with emphasis on accuracy and completeness. + Proven problem solving skills: identifies potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas. Assesses corrective action to assure it prevents recurrence. Able to confidently deal with ambiguous issues and/or rapid changes, and provide input towards suitable actions. + Excellent interpersonal skills. Effective at working with teams with diverse background, working across functions, across regions, and within a matrix organization. + Is a change agent. + Experienced with continuous improvement projects, project management, product development processes, and design control. **Education and Experience:** + B.A. or B.S. degree in health science or life science field (biology, microbiology, chemistry, engineering, medical technology, etc.) + MS degree in health science, regulatory affairs, or applicable discipline a plus + RAC/RCC Certification a plus + 5-8 years directly applicable regulatory affairs work experience preferred (e.g., 510(k), PMA, de novo, MDD and MDR compliant technical files, etc.) in a medical device company, with 1-2 year(s) experience with electrical equipment. + At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. **Why Join Us?** A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. 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. To learn more about BD visit  https://bd.com/careers 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. Required Skills Optional Skills . **Primary Work Location** USA NC - Durham - Roche Drive **Additional Locations** **Work Shift** 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.