Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryReporting 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 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 advises 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. They contribute 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. They are 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 craft 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 team members.
The RA Director facilitates the resolution for sophisticated 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.
- Develops 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 complexity.
- Coordinates 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 EU.
- Represents 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 meetings.
- Provides 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 products.
- Reviews product development and clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale.
- Leads and supervises regulatory risk mitigation and contingency planning
- Anticipates regulators’ requirements and communicates the requirements to cross-functional teams.
- Highlights key areas of risk for business management.
- Analyzes risk in terms of trade-offs through scenario planning and development of alternative approaches.
- Facilitates the risk management process by providing input as it pertains to regulatory requirements.
Serves as RA lead on Clinical Platform Leadership Team:
- Participates actively in the RA ExLT and leads cross-functional or cross-business regulatory and/or business initiatives when assigned.
- Coordinates with Quality function on compliance activities and responses to quality audit findings.
- Understands laboratory practices, customer needs, and CLIA regulations, and provides expert inputs on solutions to customers.
- Monitors 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 documents.
- Develops and influences government position and political decisions in partnership with Legal and Government Affairs.
- Establishes relationships with key advocates, regulators and internal/ external partners to ensure that BD point of view is understood and carried forward.
- Provides trends, interpretation and impact assessment to BDB partners.
- Represents BDB in external organization events at a local, regional, and national level as assigned (AdvaMed, MedTech Europe, AMDM, RAPS, etc.).
Leads and develops a complementary team of RA professionals.
- Effectively deploys appropriate management ‘standard processes’ to ensure a team of dedicated, engaged and efficient RA associates.
- 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.
- Promotes a safe, diverse, and inclusive work environment.
- 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 Regulatory Compliance personnel.
- Provides formal training (small and large-scale) and presentations to cross-functional groups within BD.
Minimum knowledge and skills:
- 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 chemistry. MS degree in health science, regulatory affairs, or applicable discipline a plus.
- RAC Certification a plus.
- Minimum 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 plus.
- Minimum of 5 years of people management experience is critical.
Primary Work LocationUSA CA - San Jose
Additional LocationsUSA CA - San Diego (BDB)
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
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.
Staff Regulatory Affairs Specialist
I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job.
Global Regulatory Operations Labeling Specialist
I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on.
Nikita A Mahendra Kumar
Senior Regulatory Affairs Specialist