Job Description Summary
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a makerof possible with us.
Want more jobs like this?
Get jobs in Warwick, RI delivered to your inbox every week.
Opportunity: Worldwide VP, Regulatory Affairs (RA) Surgery
Location: Warwick, RI (hybrid role: 4 days per week in office, when not traveling for role) - relocation assistance provided.
Reports to: VP Regulatory Affairs Management
The WW Vice President, Regulatory Affairs, Surgery will report functionally to the VP RA Management with joint accountability to the WW Business President, Surgery. The VP Regulatory Affairs, Surgery is a member of the business unit's Leadership Team. The VP RA Surgery 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 Surgery 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, Legal and other functional areas and provide his/her regulatory expertise to effectively develop 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 Surgery RA matters and ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements. The VP RA will manage a department of approximately 35 RA associates as well as partnering with regional RA teams. Additionally, he/she will also be responsible for due diligence activities to support potential mergers and acquisitions.
BD at a glance
BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety, and expand access to health care.
BD consists of three segments: BD Medical (Transforming medication preparation and administration and creating better medical outcomes), BD Interventional (Empowering healthcare workers to reduce the incidence of surgical complications, improve patient outcomes in chronic disease and lower the total cost of care), and BD Life Sciences (Investing in transformative solutions around smart, connected, end-to-end workflows and collection and diagnostics).
BD Interventional (BDI) focuses on developing innovative surgical, endovascular, urological and critical care interventions that not only meet clinical needs but also deliver value to health systems and improve patients' lives. 2 out of 3 selected surgical, peripheral and urological interventions use a BD device, aimed at advancing the treatment of high burden diseases and enabling surgical and interventional procedures. There are three business units in BDI: Peripheral Intervention (PI), Urology and Critical Care (UCC), and Surgery.
BD Surgery (one of three global businesses inside the BD Interventional (BDI) Segment)
- Surgery empowers providers to reduce the incidence of surgical complications, improve patients' experience and lower the total cost of surgical care through market leading solutions in soft tissue reconstruction & regeneration, including synthetic and resorbable mesh, biologic implants and fixation systems to complement innovative techniques for inguinal, ventral and other hernia repair procedures. We also offer an expanding line of hemostats, sealants, wound irrigation, skin antiseptics, and infection prevention products.
- Surgery has distinct portfolios (Advanced Repair & Reconstruction, Surgical Solutions)
- Revenue: $1.4B
Position Responsibilities:
- As a Member of the Surgery Business Unit Leadership Team (LT), managing direct reports in the US and a global team: 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 enable successful commercialization.
- Direct and contribute to the preparation of domestic U.S. [510(k)s, IDEs, NDAs, and PMAs] and International regulatory filings for Business Unit products in accordance with policies and procedures established by the company and regulatory agencies.
- Drive rigor in operational excellence with willingness to continuously explore opportunities for improvements.
- Collaboration with Medical function in support of clinical strategy design to support IDE filings, including novel real world evidence strategies.
- 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.
- Assessment of compliance risk in collaboration with Quality function.
- Review and approve regulatory responsibilities with business partners.
- Regularly present regulatory strategies, associated risks, and potential solutions to BU LT, BD Interventional Segment LT, and BDX ExLT 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 regarding 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. Develop organizational structure, recruitment and talent development and maintain a high level of department engagement and performance.
Education:
- 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.
Experience:
Required
- 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 with novel real-world evidence and/or clinical studies.
- 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.
- Proven experience at relationship building with Regulators worldwide.
Preferred:
- Experience in combination products, e.g., drug/device and biologics/device. Preferred NDS experience.
- Three (3+) or more years at Vice President level in a medical device company
- Experience working on FDA Warning Letters, Consent Decrees etc., and proven success in helping to resolve 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
- Familiarity with the digital environment and connected devices is a plus
- 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. Advanced degree and/or MBA highly preferred
Leadership Skills:
- 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 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.
- 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.
Travel Requirements:
- Ability to travel US and OUS travel ~15-30%
BD Critical Leadership Capabilities
- Collaborating and Influencing
- Leading People
- Strategic Thinking
- Driving Results
- Desired Outcomes
- Servant Leader
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not 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, or any other legally-protected status.
Required Skills
Optional Skills
.
Primary Work Location
USA RI - Warwick
Additional Locations
Work Shift