Sr. Director, RA

Job Description

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Sr. Regulatory Affairs (RA) Director is responsible for the management, leadership, and setting the direction for multiple product franchises or a business platform, including management of regulatory professionals within those franchises. The Sr. Director is responsible for developing and implementing regulatory strategies and submissions in support of global marketing within their respective platform. The Sr. Director determines priorities and overall structure for their platform and defines and manages expectations for projects.

The Sr. Director will work with external contacts, with US and international regulatory authorities, physician advisors, and key industry specialists as related to their product platform. The Director of RA must be knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization.

• Manage sand directs work for one or moreRAPlatformsor critical programs, including multiple product franchises and associated product lines.
• Provides regulatory leadership forrespectiveRAbusiness platform(s) or RA program(s) and manages individuals and people managers working on RA projects or teams within that platform.
• Recruits, develops, and manages RA professionals withhigherlevels of seniority,experience,and skills, and ensures regulatory milestones assigned to direct reports are met.
• Responsible for theoverallmanagementofRA Professionalswithinthe respective platform, andstructuresprojects and managersappropriatelyto ensure workis completedefficiently and effectively.
• Develops managers and technical leaders by makingaccurateassessments of individuals’ capabilities and performance, and provides feedback, coaching,guidance and mentoring.
• Manages and directs budget related to Platform(s) and/or projects, including submission costs, travel, and training for teammates.
• Partners proactively intheproduct development process toprovidestrategic guidance for development planning from the exploratory phases for new products through the ongoing compliance phases for commercialized products.
• Represents Regulatoryin Business Unitand Business  Segmentmeetings.
• Understands andanticipatesdetailed Regulatory expectations for approval, including precedence and changes in the regulatory landscape.
• Manages communications and negotiates with regulatory agencies on behalf of the business, as they pertain to regulatory decisions and strategies.
• Critically assessesimpactof studies and data on projectoutcomeand works with Senior Leadership to determine project strategy.
• Influences all parties to ensure successful submission outcomes, including submission content management.
• Coordinates with Quality function on recall strategies and responses to quality audit findings.
• Ensures consistency of messages delivered via advertising and promotion material in all arenas exposed to customer, as well as for sales training.
• RepresentsRA in due diligence andparticipatesin product acquisition teams.
• Develop sand approvesregulatory policies, goals, and executive reports.
• Communicatesinternal Regulatory Affairs procedures and policies, as needed, to people managers and developsmethod for communicating to broader regulatory group.
• Develops and influences government position and political decisions in partnership with Legal and Government Affairs.
• Builds relationships with key advocates,regulator sand internal/ external stakeholders to ensure that BD point of view is understood and carried forward.

• Comprehensive knowledge of United States, European, and international regulations and standards covering medical devices.
• Demonstrated organizational, planning, and program management skills, including action oriented, focused…