Job Description Summary

　　Reporting to BD Biosciences (BDB) Sr. Director of Regulatory Affairs, and supporting the clinical platform leader of BDB, the Director of Regulatory Affairs (RA) provides pre-market regulatory leadership to BDB, and serves as a member of the BDB Clinical Platform Leadership Team and BD RA extended LT. This individual directs the premarket regulatory affairs activities within BDB, which includes interactions between BDB and US FDA, BDB and Notified Body as well as health ministries outside of the US and EU as required. He/she contributes to the development of BDB 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 Director will ensure functional excellence in regulatory activities to achieve timely worldwide clearance, approval, registration, and licensure of BDB products with desired claims. He/she is responsible for talent development, budgets, and plans for the BDB premarket Regulatory Affairs group. Additionally, this individual plays an active role in external industry group efforts to shape policies, guidance, and standards that are of strategic importance to BDB. This individual will communicate new developments in worldwide regulations affecting BDB products to BDB stakeholders.

　　The RA Director facilitates the resolution for complex problems requiring exercise of foresight, strategic and analytical skills while exercising independent judgment and discretion within broadly defined practices and policies. This individual interprets subjective and complex aspects of specific regulations and has a general understanding of multiple sets of associated regulations.

　　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.

　　Job Responsibilities:

　　Reporting to BD Biosciences (BDB) Sr. Director of Regulatory Affairs, and supporting the clinical platform leader of BDB, the Director of Regulatory Affairs (RA) provides pre-market regulatory leadership to BDB, and serves as a member of the BDB Clinical Platform Leadership Team and BD RA extended LTDirects the premarket regulatory affairs activities within BDB, which includes interactions between BDB and US FDA, BDB and Notified Body as well as health ministries outside of the US and EU as requiredContributes to the development of BDB strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programsEnsures functional excellence in regulatory activities to achieve timely worldwide clearance, approval, registration, and licensure of BDB products with desired claimsResponsible for talent development, budgets, and plans for the BDB premarket Regulatory Affairs groupPlays an active role in external industry group efforts to shape policies, guidance, and standards that are of strategic importance to BDBCommunicates new developments in worldwide regulations affecting BDB products to BDB stakeholdersDevelops regulatory strategy for IVD and CDx and ensures timely execution of the strategy and activities related to US and EU registrations, and designated compliance activities from moderate to high complexityCoordinates and advises the preparation of complex regulatory submissions, including Premarket (510(k)) Notifications, de novo applications, EU Technical Files for CE mark (IVDD/IVDR, and Machinery Directive), pre-Submission documentation, Premarket Approval Applications (PMA), laser reports, WHO pre-qualification submissions, and materials required for registration of products outside the U.S. and EURepresents the business in interactions and negotiations with regulatory agencies and notified bodies about premarket submission requirements, acceptable labeling claims, etc.Organizes and leads meetings with regulators, including development of agendas, preparation of materials, and training/preparation of company personnel attending the meetingsProvides a high degree of regulatory expertise and experience to BDB's new product development programs, serving as a Core Team advisor and champion for BDB'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 IVDs, and research use only productsReviews product development and clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory complianceLeads and supervises regulatory risk mitigation and contingency planningParticipates actively in the RA ExLT and leads cross-functional or cross-business regulatory and/or business initiatives when assignedCoordinates with Quality function on compliance activities and responses to quality audit findingsUnderstands laboratory practices, customer needs, and CLIA regulations, and provides expert inputs on solutions to customersMonitors and shapes US and EU laws, regulations, guidance, and standards pertaining to IVD clearance/approval. This includes, but not limited to: Influences and interprets guidance documentsDevelops and influences government position and political decisions in partnership with Legal and Government AffairsEstablishes relationships with key advocates, regulators and internal/ external partners to ensure that BD point of view is understood and carried forwardProvides trends, interpretation, and impact assessment to BDB partnersRepresents BDB in external organization events at a local, regional, and national level as assigned (AdvaMed, MedTech Europe, AMDM, RAPS, etc.)Effectively deploys appropriate management 'standard processes' to ensure a team of dedicated, engaged and efficient RA associatesDrives improvements in capability, such as customer centricity, regulatory knowledge, project leadership skills, effective team participation and communicationInstills a culture of continuous improvement by identifying and implementing improvements to support and achieve functional excellenceParticipates 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 Regulatory Compliance personnel.

　　Qualifications:

　　Experienced knowledge in US IVD and EU IVD (both IVDD and IVDR) regulations. Solid understanding of rest of the world regulatory requirements.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 leadership skills with ability to develop, influence and lead others; encourages and empowers others. Inspires effective functional unit dynamics and imparts a sense of commitment to business goals. Recognized and respected as a leader.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.), or B.A. or B.S. degree other related discipline with significant coursework in biology and chemistryMS degree in health science, regulatory affairs, or applicable discipline a plusRAC Certification a plusMinimum of 8 years directly applicable regulatory affairs work experience (e.g., IVD 510(k), PMA, de novo, IVDD and IVDR compliant tech files, etc.) in a medical device company. Flow cytometer related experience/knowledge a super plusMinimum of 5 years of people management experience is critical

　　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.

　　Primary Work Location

　　USA CA - San Jose

　　Additional Locations

　　USA CA - San Diego (BDB)

　　Work Shift

　　At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

　　Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

　　Salary Range Information

　　$187,400.00 - $337,300.00