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 SummaryThe WW Vice President, Regulatory Affairs, Integrated Diagnostic Solutions reports directly to the BD Life Science Segment VP Regulatory Affairs and the President of the Integrated Diagnostic Solutions Business Unit. This position is responsible for the WW IDS regulatory functional excellence and strategy that supports the business growth agenda, including overall regulatory strategy, execution, operations, and talent management of IDS RA.
The WW Vice President, Regulatory Affairs, Integrated Diagnostic Solutions reports directly to the BD Life Science Segment VP Regulatory Affairs and the President of the Integrated Diagnostic Solutions Business Unit. This position is responsible for the WW IDS regulatory functional excellence and strategy that supports the business growth agenda, including overall regulatory strategy, execution, operations, and talent management of IDS RA. Regulatory operations include systems for sensing/managing the global regulatory environment, establishing the regulatory affairs annual operating portfolio plan, ensure function compliance with reg ops systems (RIM, Knowledge Exchange) and driving the efficient delivery of high quality regulatory submissions that shorten time to market.
The VP RA must be the strategic thought partner to the business president, supporting the growth agenda in key strategic initiatives. S/he must collaborate effectively with Business Groups, R&D, Marketing, Clinical/Medical Affairs, and other functional areas to provide his/her regulatory expertise to effectively develop regulatory strategies that successfully lead products through the FDA clearance/ approval process, as well as other global regulatory agencies.
Serves as a member of the IDS Business Unit Leadership Team, Portfolio Management Team (PMT), and the Corporate RA Extended Leadership Team.
- Proactively support the IDS business growth by partnering with IDS president, business group leaders and other functions on key strategic initiatives
- Accountable for the functional excellence of the IDS premarket submissions program worldwide.
- Serves as the senior IDS regulatory representative to FDA and other regulatory bodies, industry trade associations, IDS Leadership teams, and Corporate Regulatory Affairs.
- Oversee the Specimen Management Warning Letter Regulatory support by strongly guiding and coaching the RA team, aligning with overall Specimen Management strategy.
- Ensures IDS regulatory affairs is a strategic partner to the businesses – coordinates regulatory strategies and tactics with the business plan – to drive growth, innovation, and profitability
- Monitors the regulatory environment and proactively advises senior leadership and stakeholders regarding new regulatory/standards developments that can materially affect the business.
- Advocates favorable regulations and guidelines that support timely patient access to safe/effective Dx
- Develops and implements IDS-wide policies and best practices that ensure efficient and effective compliance with FDA and international requirements
- Leads the design, content, and format for regulatory submissions, such as PMAs, 510(k)s, PMA Submissions, and EU Technical Files. Provides training and education to stakeholders.
- Supports the design of efficient and effective clinical trials that are conducted in compliance with GCPs
- Ensures timely reviews and approvals of technical data, labeling and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.
- Identify, develop and coach key regulatory talents
- Build strong capabilities and leadership skills, growth mindset and innovation culture
- Develops regulatory talent management programs to create a sustainable pipeline of talent
- Expected to travel regularly to Franklin Lakes to guide and coach Specimen Management Regulatory team
- Required - Bachelor of Science degree in a technical discipline (e.g., biology, chemistry or engineering)
- Advanced degree (MS,PhD, etc) preferred
- RAPS Regulatory Affairs Certification (RAC) preferred
- 15+ Years of industry experience with 5+ years leading a Regulatory Affairs team
- Demonstrated track record of success in leading all areas of regulatory affairs for medical devices, specifically in vitro diagnostic devices.
- Experience with FDA Class I, II, and III products.
- Extensive knowledge and experience in designing global regulatory strategies and ensuring timely submission of high quality documents for medical device product registrations. Regulatory strategies may include clinical strategies for products requiring clinical data for regulatory approval or clearance.
- Significant experience gaining regulatory approvals for medical devices outside of the United States.
- A proven track record of recruiting, developing, and retaining a high performance team.
- Past success operating in a large, matrix-managed organization.
- Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
- Strong business orientation - ability to communicate and interact effectively with senior BD business leaders in US and around the world.
- Demonstrated success in filing and completing (including negotiations) a large number of regulatory submissions/dossiers (e.g., 510(k), IDE, PMA, EU Technical Files).
- Must inspire, motivate, and build the confidence of teams to reach goals, steadfastly pushing self and others to achieve results.
- Demonstrate leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed.
- Demonstrate success in supporting both growth and product support projects, including complex projects involving ambiguity, in a rapidly changing regulatory environment
- 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, mentor, and retain high-caliber professionals.
KNOWLEDGE OF SPECIFIC PROCEDURES / PRACTICES:
Comprehensive knowledge of regulatory requirements and strategies 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 travel US and OUS approximately 15-30%
NUMBER OF INDIVIDUALS SUPERVISED:
Oversees a function of 50 or more professional or administrative associates.
Responsible the planning and management of the budget for the IDS RA function, and for the project toward achieving compliance with the EU Medical Device Regulations / In Vitro Diagnostic Device Regulations.
Applicable BD and IDS policies relating to Human Resources, Regulatory and Quality, and Ethics.
Highly complex. This position influences the development of IDS business group strategic plans and provides important input into key business decisions. Regulatory assessments and recommendations influence the product portfolio plans, scientific or technical direction of product design and/or development. Erroneous decisions or recommendations may cause delays in meeting business objectives, including financial goals. The incumbent is expected to demonstrate highly advanced skills and knowledge as a business leader in regulatory matters.
Primary Work LocationUSA MD - Sparks - 7 Loveton Circle
Additional LocationsUSA NJ - Franklin Lakes
Work ShiftNA (United States of America)
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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.
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