Sr. Director, RA

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.

TheSr.Regulatory Affairs(RA)Directoris responsible forthe management, leadership,andsettingthedirectionformultiple product franchisesor abusiness platform, including management of regulatory professionals within those franchises. TheSr.Directorisresponsible fordeveloping and implementing regulatory strategies and submissionsin support of global marketingwithin their respectiveplatform.The Sr. Directordeterminespriorities and overall structure for theirplatform anddefines and manages expectationsfor projects.TheSr.Directorwillwork withexternal contacts,with US and international regulatory authorities, physician advisors, and key industry specialistsas related to their product platform.The Director ofRAmust be knowledgeable about current andpossible futurepolicies, practices, trends,technologyand information affecting the business and organization.

Responsibilities:

• Managesand directs work for one or moreRAPlatformsor critical programs, including multiple product franchises and associated product lines.
• Provides regulatory leadership for respectiveRAbusiness platform(s)or RA program(s) andmanages individuals and people managersworking on RA projects or teamswithin 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 theoverallmanagement ofRA 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,guidanceand 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.
• RepresentsRegulatoryinBusinessUnitandBusiness 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 tocustomer, as well as for sales training.
• RepresentsRA in due diligence andparticipatesin product acquisition teams.
• Developsand approvesregulatory policies, goals, and executive reports.
• Communicatesinternal Regulatory Affairs procedures and policies, as needed, to people managers and developsmethodfor communicating to broader regulatorygroup.
• Develops and influences government position and political decisions in partnership with Legal and Government Affairs.
• Builds relationships with key advocates,regulatorsand 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 changeand can comfortably 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
• Demonstrated self-starter, and highly motivated
• Excellent written and verbal communication skills including ability to communicate across culture; work with others inteamenvironment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators.
• Ability to interpretmedical device testing methods and statistics, as applicable.
• Knowledgeable about current andpossible futurePolicies, practices, trends,technologyand information affecting the business and organization.
• Advance degree preferred.
• RAC certification.
• Experience with Clinical Trialapplications(US IDE).
• Medical device experience in Oncology,ESKDand/or PAD.

Education and/or Experience:

• Bachelor’s degree or advanced degree in technicalareasuch as biology, chemistry, engineering or medical-related fieldand a minimum oftenyearsofexperience, or equivalent combination of related education and experience.
• Preferred minimum often-to-fifteenyears of experience inthemedical device industry, with at leasttenyears in aregulatory role.

Physical Demands:

While performing the duties of this job, the employeeis regularly required tostand, walk, sit, use sight, and use hands to manipulate,handleor feel objects, tools, controls, and office equipment. The employeefrequentlyis required toverbally communicate with other associates. The employeeis occasionally required toreach with hands and arms and stoop, kneel or crouch. Inabilityto meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primaryresponsibilities ofand qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may berequiredeither now or in the future.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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. 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.

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 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.

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.

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.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit _https://bd.com/careers_.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.