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BD (Becton, Dickinson and Company) VP Regulatory Affairs MDS in Franklin Lakes, New Jersey

Job Description Summary

Position Summary:

The WW Vice President, Regulatory Affairs, MDS reports to both the President of the MDS Business Unit and the VP Regulatory Affairs, Medical Segment. The VP RA for MDS 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 MDS 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 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 MDS RA matters and ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements. The VP will manage a department of approximately 75-90 RA associates based in New Jersey, Utah California and Switzerland 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.

Job Description

Position Responsibilities:

  • As a Member of the Business Unit Leadership Team (LT), managing direct reports in the US: 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 BU LT, BD Medical 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 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 working with electromechanical 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

Preferred:

  • Experience in combination products, e.g., drug/device and biologics/device

  • 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 required. 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 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.

Travel Requirements:

  • Ability to travel US and OUS travel 15-30%

“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.”

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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, or any other protected status.

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, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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