JOB DESCRIPTION SUMMARY JOB DESCRIPTION TITLE Vice President, Regulatory Affairs JOB CODE 100270 GRADE JG7 DEPARTMENT Regulatory Affairs DATE April 20, 2021 POSITION SUMMARY: The Vice President, Regulatory Affairs will be a member of the Vascular Access Devices (VAD) Business Group Leadership team. The VP of RA will be responsible for directing all regulatory affairs activities for VAD to ensure the business unit, corporate and agency global product registration and compliance objectives are met. The VP RA must be able to collaborate with R&D, Marketing and other functional areas to provide his/her regulatory expertise to effectively develop regulatory strategies that successfully lead VAD's products through the FDA approval process, as well as the numerous other global regulatory agencies. The position reports directly to the WW VP RA MDS Business Unit, with a dotted line to the President/ GM VAD. MINIMUM QUALIFICATIONS: This position requires:

• Bachelor's degree.
• Demonstrated track record of success in leading all areas of regulatory affairs for U.S. medical devices.
• Extensive knowledge and experience in designing regulatory and clinical strategies and submissions of product registrations for medical devices.
• Minimum of ten (10) years of experience in a medical device company with broad experience surrounding regulatory affairs.
• A proven track record of building an effective regulatory affairs team. Preferred qualifications include:
• Experience in drug/device combination products.
• Five years as a Sr. Director or Vice President level in a medical device company.
• Past success operating in a large, matrix-managed organization.
• Bachelor's or advanced degree in the physical sciences, biomaterials or related field.
• Significant experience gaining regulatory approvals for medical devices outside of the United States.

The incumbent must demonstrate the ability to perform the essential functions of the job as outlined in the duties and responsibilities. ESSENTIAL DUTIES & RESPONSIBILITIES: The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

• Ensure worldwide regulatory strategies are clearly delineated, supported and implemented in the development, commercialization and life cycle management of the business's products.
• Member of the VAD Leadership team and VAD Management Committee.

TITLE Vice President, Regulatory Affairs JOB CODE 100270 GRADE JG7 DEPARTMENT Regulatory Affairs DATE May 2018 ESSENTIAL DUTIES & RESPONSIBILITIES CONTINUED:

• Lead the development of global regulatory strategies and timelines for VAD product development projects, working through cross-functional teams to ensure that various pathways are examined early in the process. An assessment of the business risks associated with the preferred regulatory strategies, along with the mitigation plans must be presented to the project team and VAD management in order to keep commercialization progress on track.
• Direct and contribute to the preparation and submission of domestic U.S. [510(k)s, IDEs, and PMAs] and International regulatory filings for the business group products in accordance with policies and procedures established by the company and regulatory agencies
• Provide appropriate interface for VAD 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. Maintain active involvement in medical device and regulatory affairs organizations to ensure up-to-date knowledge of current and future industry trends.
• Develop and maintain outstanding relationships with all regulatory and compliance agencies. Serve as liaison between VAD, the FDA, and other international regulatory submission agencies
• Lead regulatory due diligence assessments and recommendations for acquisitions and/or partnering and product distribution agreements.
• Spearhead the development and implementation of world class policies and procedures in conjunction with MDS and BDX Corporate to enhance operation of the department and ensure overall regulatory compliance.
• Ensure that VAD product labeling and promotional materials are in compliance with FDA, Corporate, and International regulations and requirements.
• Communicate the regulatory affairs strategy to the entire VAD team and each key functional area to inspire proactive attention to this critical area within the company.
• 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 VAD employees about global regulatory requirements and BDX regulatory affairs polices & procedures
• Provide timely information to the Business Unit and MDS management on issues and accomplishments, performance metrics and significant events
• Participate as a key member of the Product Development Team.
• Assess the skills and competencies of the Regulatory, in alignment with the short- and long-term objectives of the VAD Business Group. Recruit, develop and retain professionals who demonstrate exceptional performance and leadership potential.

TITLE Vice President, Regulatory Affairs JOB CODE 100270 GRADE E17 DEPARTMENT Regulatory Affairs DATE May 2018 ESSENTIAL DUTIES & RESPONSIBILITIES CONTINUED:

• Ensure bench strength and succession planning through appropriate recruiting, staffing and development of team members.
• Motivate, mentor and inspire VAD department employees for success including goal setting, performance management, career planning and ongoing evaluation of both individual and departmental operations.
• Control operational expenses in functional area of responsibility. Actively participate in the preparation of overall expense budget and headcount forecast for Regulatory Affairs.

KNOWLEDGE & SKILLS:

• Ability to work effectively with FDA and other regulatory agencies.
• Excellent management skills including a proven track record of developing and nurturing high potential individuals.
• Ability to function as an active member of the Leadership Team.
• Ability to function in a matrix reporting relationship and a team environment.
• Excellent verbal and written communication skills.
• Strong understanding of global regulatory environment for medical devices.

PHYSICAL REQUIREMENTS: This position is in an office and laboratory environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty-five pounds occasionally. The incumbent may be required to stand for extended periods of time. Bending, stooping and reaching may also be required. PRIMARY WORK LOCATION USA UT - Salt Lake City BAS ADDITIONAL LOCATIONS WORK SHIFT

BD is a Fortune 500 global medical technology company headquartered in Franklin Lakes, New Jersey, with offices in more than 50 countries. The company operates three business segments: BD Medical, BD Life Sciences and BD Interventional. 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 the design and engineering, to the manufacturing and the marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.