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 Vice President, Regulatory Affairs reports to the BD Segment VP Regulatory Affairs and is a member of the business unit’s Leadership Team. The VP Regulatory Affairs will be responsible for developing and executing global regulatory strategies designed to obtain regulatory approvals to support the business plan. The position will lead and direct all regulatory affairs activities for the business unit, including global product registration and compliance objectives. The VP RA must be able to collaborate effectively with 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. The position will serve as the chief contact and spokesperson for communication with global regulatory agencies on business unit matters and ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements. The VP will manage a department of RA associates at a BD site as well as various international locations and will assure consistency of approach and optimal utilization and development of talent for the business unit. Additionally, he/she will also be responsible for due diligence activities to support potential mergers and acquisitions.
- As a Member of the Business Unit Leadership Team (LT), managing direct reports in the US and OUS: Collaborate with cross-functional teams to ensure that various regulatory pathways are reviewed and challenged early in the development process.
- Develop and present an assessment of the business risks associated with the preferred regulatory strategies, along with the mitigation plans, to the project team and management in order to keep commercialization progress on track.
- Direct and contribute to the preparation of domestic U.S. [510(k)s, IDEs, and PMAs] and International regulatory filings for Business Unit products in accordance with policies and procedures established by the company and regulatory agencies.
- Provide appropriate interface with global regulatory agencies in a variety of pre- and post-market forums. Provide guidance, interpretation and opinions on complex regulatory matters (particularly related to submission pathways), outlining the different outcomes.
- Develop and maintain outstanding relationships with all regulatory and compliance agencies. Serve as liaison between the Business Unit, the FDA, and other international regulatory agencies.
- Lead regulatory due diligence assessments and recommendations for acquisitions and/or partnering and product distribution agreements.
- Review and approve regulatory responsibilities with business partners.
- Regularly present regulatory strategies, associated risks, and potential solutions to business unit LT, Segment LT, and BDX XLT members.
- Review and ensure product labeling and promotional materials are in compliance with FDA, Corporate, and International regulations and requirements.
- Provide technical leadership, training and vision by interpreting regulatory affairs initiatives and mandates, uncovering emerging trends and providing the processes necessary to meet rising expectations.
- Assist in the training of employees with regard to global regulatory requirements and regulatory affairs polices & procedures.
- Control operational expenses in functional area of responsibility. Actively participate in the preparation of overall expense budget and headcount forecast for Regulatory Affairs.
- Review and understand the compliance risk areas to ensure RA policies and procedures, regulatory decisions, and regulatory strategies for product registrations are consistent with the requirements of the FDA and other regulators.
- Review and understand the international regulations to ensure appropriate decision making, organizational structure, and implications to product acquisitions, sales, and how it impacts the ability to market the business unit’s products globally.
- Develop organizational structure, recruitment and talent development and maintain a high level of department engagement and performance.
- B.S. or B.A. degree in a technical discipline (biology, chemistry or engineering preferred); advanced degree and/or MBA preferred.
- RAPS RAC (U.S.) preferred.
- 15+ Years 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.
- Past regulatory experience working with complex medical device systems and/or medical devices that incorporate software.
- 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.
- Three (3+) or more years at a Sr, Director or Vice President level in a large medical device company.
- Experience working in RA for complex medical device systems.
- Experience working on compliance remediation and proven success in resolving FDA and other regulatory agency compliance challenges.
- Someone who can think and work proactively and strategically, both from a technical (micro) and business partner (macro) level
- Ability to work and think globally with teams is very important for a leader in this business, i.e. past product geo-expansion experience.
- Ability to successfully lead and support other major global regulatory initiatives for the business, such as the new EU Medical Device Regulations (EU MDR)
- Bachelor’s degree in Life Sciences or Engineering required. Advanced degree and/or MBA highly preferred.
- 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
- Ability to anticipate the business needs and align RA strategies with business strategies
- Ability to work well in a team environment and demonstrate flexibility and resilience in a fast-paced work environment.
- Ability to attract, coach/mentor and develop global organizational talent.
- Recognized externally as active in improving the industry; proactive in external standards boards, industry groups, and policy working teams.
- Ability to travel US and OUS travel ~25-40%
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsUSA DC - Washington, DC
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
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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