BD (Becton, Dickinson and Company) Vice President Regulatory Affairs PAS in Franklin Lakes, New Jersey
Job Description SummaryBD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. BD is headquartered in the United States and has offices in nearly 50 countries worldwide.
BD focuses strategically on achieving growth in three worldwide business segments - Medical, Life Sciences and Interventional. This strategic focus coupled with excellence in operational execution has resulted in record financial performance.
BD Preanalytical Systems (PAS) is the industry pioneer and leader in the area of modern evacuated blood collection systems, including evacuated tubes and needles - The Home of the BD Vacutainer® and Microtainer® Brand and families of products in venous, capillary and urine collection, transfer and transport.
Integrated systems for specimen collection
Safety-engineered blood collection products and systems
Hospitals, laboratories and clinics
Physicians’ office practices
Public health agencies
Clinical laboratories, like other parts of our healthcare system, are striving to provide high-quality services in the face of ever-shrinking resources, an uncertain reimbursement climate, and increasing regulatory demands. To demonstrate value to their institutions and secure the necessary investment for their departments, lab directors and managers are seeking to optimize processes, enhance efficiency, decrease risk, and reduce overall costs wherever possible. More and more, they are viewing the preanalytical phase of laboratory testing as a critical area for improvement that can drive not only better patient care and satisfaction, but also substantial productivity gains and cost savings. Fortunately for BD Preanalytical Systems, we have the right solutions to meet these needs. For more than 60 years, BD has served as the pioneer and leader in the science of specimen collection. Over that time, we have developed deep expertise that complements our comprehensive product portfolio. Our customers draw upon both of these assets to derive maximum value from their preanalytical processes. Our expert team of Technical Services and Medical Affairs representatives, Care Consultants, Lean-Sigma Consultants, and Sales Consultants help customers understand how their institutions are performing on key preanalytical metrics, such as hemolysis, urine contamination, and needle stick injuries. Then, they can help implement improvements.
BD is dedicated to producing solutions - and the best solution of all is helping all people live healthy lives. Our vision is to be a great company, defined by great performance, great contributions made to society, and being a great place to work. For additional information, please visit:
The PAS Vice President Regulatory Affairs reports to the Vice President Regulatory Affairs, Life Sciences Segment and is responsible for developing and executing global regulatory strategies designed to obtain regulatory approvals to support the business plan. With minimal supervision, he/she will lead the PAS Regulatory Affairs department; assuring products, services and communications meet global regulatory requirements and meet the needs of the business. He/she will serve as the chief contact and spokesperson for communication with global regulatory agencies on PAS matters and ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements. He/she will provide sound regulatory guidance and oversight to other groups within the PAS business unit including but not limited to research, product development and manufacturing organizations. He/she will provide guidance on regulatory issues related to advertising, labeling, public disclosures, corporate communications and other public relations activities relating to the PAS business. He/she will manage a department of approximately six RA associates based in New Jersey and will assure consistency of approach and optimal utilization and development of talent for the PAS business unit. Additionally, he/she will also be responsible for due diligence activities to support potential mergers and acquisitions.
Provides regulatory leadership to the PAS Platform Teams, Leadership Team and Portfolio Decision Team.
Works closely with leadership team members to ensure alignment of regulatory strategies with business objectives. Creates and execute strategies that improve time to market, lower product develop costs and provides competitive advantage
Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders.
Is the primary contact for BD PAS in interactions/negotiations with U.S. regulatory agencies and enables and empowers staff to interact and negotiate with regulators as well.
Represents BD’s interests in external activities benefiting BD, including trade associations, professional organizations, and standards development organizations.
Manages and develops a staff of regulatory professionals carrying out product submission/registration activities. Assesses resource requirements based on business priorities and allocates personnel as required to meet these objectives.
Directs the preparation and filing of premarket submissions (510(k)s, de novo submissions, PMAs, and Technical Files), and the preparation of content for other ex-U.S. registrations.
Monitors global regulatory developments affecting PAS programs and products and communicates emerging opportunities and concerns to stakeholders.
Manages the regulatory review of labels, labeling, and promotional materials and sets policies to ensure consistency in these reviews.
Hires, develops and retains staff to meet business needs and to create a pipeline of talented professionals for progressively challenging and responsible roles.
Actively participates on a regular basis in the career development of direct reports and provides opportunities to grow in current role and advance to more positions with more responsibilities.
Develops direct reports with regard to required competencies, including, but not limited to, regulatory knowledge and ability to apply this knowledge, effectiveness in team and one-to-one interactions, and verbal and written communications.
Drives continuous improvement of regulatory processes.
Delegates effectively and assigns clear accountability to staff and sets aggressive, yet realistic goals for completion of assigned tasks.
Develops best-in class-functional processes. Ensures functional skills and competencies are reinforced with appropriate tools, templates, and metrics that are integrated into the product development processes.
Works closely with peers and regulatory functions throughout BD, especially those in the same segment, unit and location. Works with the global BD Regulatory Affairs function to help cross-train and utilize employees and develop functional excellence
Plans and implements departmental budget.
B.S. or B.A. degree in a technical discipline (biology, chemistry or engineering preferred).
RAPS RAC (U.S.) preferred.
- Minimum fifteen years of directly related experience in increasingly responsible positions in the medical device or diagnostic industry, and ten or more years of management experience.
SKILLS & KNOWLEDGE
Ability to think critically, and strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
Ability to communicate and interact effectively across all levels, disciplines, and regions, particularly with members of the leadership team.
Ability to inspire, motivate, and build the confidence of teams to reach goals, steadfastly pushing self and others to achieve results.
Demonstrates leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed.
Demonstrated success in supporting both growth and product support projects, including complex projects involving ambiguity and rapid change.
Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers (e.g., 510(k), IDE, PMA, EU Technical Files).
Experienced in meeting with, making presentations to, and negotiating with regulators.
Demonstrated success in developing strong working relationships with regulators and external groups (e.g., trade associations) in order to influence effectively and bring about consensus on policies that support business objectives.
Ability to attract, recruit, develop, and retain high-caliber professionals.
Comprehensive knowledge of regulations applying to medical devices and in vitro diagnostic devices in the U.S., EU, Canada, Japan, Asia Pacific, and Latin America.
Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.
Ability to apply broad knowledge and seasoned experience to address complex and critical issues.
Promotes a collaborative environment and removes obstacles to teamwork across the organization.
Primary Work LocationUSA NJ - Franklin Lakes
Work ShiftNA (United States of America)
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