Sr. Director, RA

We are the people who give possibilities purpose 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. 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 maker of possible with us.  The   Sr.   Regulatory Affairs   (RA)   Director   i s 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 k nowledgeable about current and   possible future   policies, practices, trends,   technology   and information affecting the business and organization.   Responsibilities:    Manages   and directs work for one or more   RA   P latforms   or critical programs , including multiple product franchises and associated product lines .   Provides regulatory leadership for   respective   RA   business p latform(s)   or RA program (s ) and   manages individua ls and people managers   working on RA projects or teams   within that platform .      Recruits, develops, and manages RA professionals with   higher   levels of seniority,   experience,   and skills, and ensures regulatory milestones assigned to direct reports are met.     Responsible for the   overall   management of   RA Professionals   within   the respective platform, and   structures   projects and managers   appropriately   to ensure work   is completed   efficiently and effectively .      Develops managers and technical leaders by making   accurate   assessments 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 in   the   product development process to   provide   strategic guidance for development planning from the exploratory phases for new products through the ongoing compliance phases for commercialized products.   Represents   Regulatory   in   Business   Unit   and   Business Segment   meetings .   Understands and   anticipates   detailed 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 assesses   impact   of studies and data on project   outcome   and 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.    Represents   RA in due diligence and   participates   in product acquisition teams.     Develop s   and approves   regulatory policies, goals, and executive reports.   Communicate s   internal Regulatory Affairs procedures and policies , as needed , to people managers and develops   method   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,   regulators   and internal/ external stakeholders to ensure that BD point of view is understood and carried forward.   Required Qualifications:   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 urgency and driving for results   Experienced in continuous improvement projects, project management, product development processes, and design control.   Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently.     Effectively copes with change   and can co mfortably handle risk and uncertainty .    Prior management experience     Preferred Qualifications:   Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.    Ability to be effective in complex projects with ambiguity and/or rapid change   Demons