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 Summary
The Vice President, Regulatory Affairs for the BD Interventional Segment (BDI) is responsible for developing and executing global regulatory strategies to support the Segment business objectives. This role will oversee RA for three worldwide business units: Surgery, Urology and Critical Care (UCC) and Peripheral Intervention (PI). The VP of RA BDI will serve as the chief contact and spokesperson for BDI Segment engagement with global regulatory agencies and ensure that company policies, procedures and practices are in compliance with relevant U.S. and global regulatory requirements. This role will provide senior leadership oversight for the Regulatory Affairs teams in the three business units as well as providing regulatory expertise to the segment and corporate Regulatory Affairs teams. The VP RA for the BDI segment will also be responsible for establishing and leading a Regulatory Affairs Training Center of Excellence (COE). This COE will develop and delivery training on new regulations and policies across the organization. He/She will also lead the Regulatory Affairs Governance Process ensuring that corporate regulatory policies are in place to ensure ongoing compliance to global regulations. This position is a member of the BDI Segment Leadership Team and the RA Leadership Team.
The VP of BDI RA will provide sound regulatory guidance to the segment and collaborate with R&D, Marketing, Clinical/Medical Affairs, Quality, the Regions and others to provide his/her regulatory expertise to advise on segment-level business strategies and execution of business objectives. He/She will provide guidance to the regulatory leaders of the business units within the segment on regulatory issues related to registration strategies, risk assessments, registration compliance matters, advertising and promotion, labeling, public disclosures, Corporate communications and other public relations activities, among other matters that could materially impact the business units and/or segment. In this segment role, the incumbent will assure consistency of approach and optimal utilization and development of talent for the BDI Business Units regulatory affairs departments. Additionally, the VP of RA BDI will be responsible for leading any regulatory projects that impacts all three business units (i.e., EU MDR) as well as due diligence activities to support potential mergers and acquisitions across the segment. This segment leadership role has responsibility for approximately $4B in annual revenue for the combined business units, with top-level Business Unit RA leadership reporting directly into this position.
BDI Segment RA Leader Responsibilities
- Responsible for developing and executing the vision of the regulatory affairs group to achieve the strategic plan of the BDI Segment in alignment with BDI’s Business Objectives.
- Provides oversight and works with the Business Unit Regulatory teams within the BDI Segment to ensure consistency in regulatory activities, implementation of the regulatory strategy, risk management and continuous improvement projects across the Segment to achieve business objectives.
- Review and advise on all material FDA and global regulatory submissions/or registration strategies for product approvals or clearances. Review and approval of all FDA AI requests and other regulatory agency inquiries.
- Review and advise RA and Business Unit leadership on product risk assessments and global change assessments.
- Oversee risk management activities that can impact registration or business growth strategies of the business units within the BDI Segment.
- Support appropriate prioritization of projects managed by RA business unit teams to ensure business objectives and regulatory obligations are met.
- Assess the skills and competencies of the Regulatory professionals across the BDI Segment and ensure succession planning. Build a team with capabilities to support the short-, mid- and long-term goals of the BDI Segment.
- Motivate, mentor and inspire employees for success and advance the BD culture through training, goal setting, performance management, career planning and ongoing evaluation of both individual and departmental operations.
- Accelerates growth by developing regulatory strategies and tactics, including building external partnerships, designed to achieve global product clearances and approvals faster and in compliance with relevant regulations and law.
- Responsible for influencing and shaping global medical device regulations by monitoring and engaging in regulatory policy and advocacy efforts in conjunction with the Public Policy team to support the goals and strategic plans of the BDI Segment.
- Actively participates on the BDI Segment leadership team to achieve business objectives, and execute on short-term and long-term segment level strategies.
- Actively participates on the RA Leadership team to advance and support the execution of RA strategies that impact BD-wide business objectives, RA governance, sharing of best practices, centralizing subject matter RA expertise on specific topics (i.e., COEs), guidance on transformative regulations (i.e., EU MDR, MDUFA), regulatory operation projects, among other things.
- Improves operational effectiveness by utilizing Lean Thinking principles and Six Sigma tools to examine and improve the efficiency and effectiveness of procedures, processes and systems used by the regulatory affairs group while increasing awareness of the BD RA standards by which associates should operate in compliance with regulations and law.
- Participates in regulatory trade associations, professional organizations, and standards development organizations.
RA Training Center of Excellence Responsibilities
- Leverages internal and external experts to develop and deliver training on new regulations, guidance and corporate regulatory policies
- Partners with global regulatory policy and intelligence sense emerging regulations to anticipate training needs on how assess impact to BD.
RA Governance Leader Responsibilities
- Leads a team accountable for overseeing the development, maintenance and training for corporate regulatory policies and procedures.
- Ensures new and existing policies are up to date and compliant to global regulations.
- Partners with Quality to ensure policies and procedures align with the BD Quality System.
- Bachelor of Science Degree in a Life Science or Engineering field is required.
- Preference for an Advanced Degree
Bachelor’s Degree in a life science or engineering required. Advanced degree preferred (MS, PhD, MBA).
Minimum of 10-15 years of medical device and/or pharmaceutical experience, directly working on regulatory filings required.
Minimum of 7 – 10 years' people management required.
Must have recent experience leading meetings with FDA/CDRH for new device products.
RAC certified a plus, but not required.
- Interprets subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated national regulations, and general knowledge of international regulations. Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. Recognized internally as subject matter expert in multiple areas.
- Communicates (oral/written) with groups and negotiates issues, including complex or sensitive issues.
- Independently authors written reports/documents for distribution within division.
- Recognizes potential problems and proposes solutions, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors.
- Assesses potential impact and/or applicability to other related areas within unit and business.
- Assesses corrective action to assure it prevents recurrence.
- Able to confidently deal with ambiguous issues and provide input towards suitable actions.
- Suggests significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex or involve multiple organizational areas.
- Analyzes feasibility and participates in developing, executing, or monitoring implementation plan.
- Manages and monitors multiple complex and diverse projects simultaneously, including projects that involve several functional areas.
- Maintains a “focused urgency” as required by specific events.
- Proven track record of recruiting, developing, and retaining a high performance team.
Travel: Approx. 25-30% US and International Travel.
- Ability to link regulatory strategy, tactics, and outcomes to business strategy
- Ability to create and sustain a results-oriented culture
- Strong business acumen
- Ability to influence through effective communication, people management, and leadership skills.Critical competencies include: leadership, financial and business acumen, dealing with ambiguity, organizational agility, and strategic thinking
Complexity of Duties:
- Working in a matrix, across organizational boundaries and within ambiguous environments.
- Works on complex issues in a cross-cultural business environment.
- Ability to manage multiple priorities at the same time.
- Must operate with a sense of urgency.
Primary Work LocationUSA NJ - Franklin Lakes
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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.
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