BD
Job Description Summary
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 Regulatory Affairs (RA) Director is responsible for managing and setting the strategic direction for the Medication Delivery and Vascular Care (MDVC) business platform within the Medication Delivery Solution Business Unit. The RA Director develops and implements regulatory strategies and submissions to support global marketing within the MDVC platform. This role involves collaboration with external contacts, US and international regulatory authorities, physician advisors, and industry specialists, requiring a comprehensive understanding of current and future policies, practices, trends, technology, and information affecting the organization.
Responsibilities:
Manage and direct work for multiple product families, RA projects, or a Regulatory Affairs platform.
Provide regulatory leadership for the respective platform, product families, or RA programs, managing RA managers and team members.
Recruit, develop, and manage RA professionals, ensuring regulatory milestones are met.
Oversee the management of RA professionals within the platform(s) or program(s), structuring projects for efficiency.
Develop managers and technical leaders through performance assessments, feedback, coaching, and mentoring.
Manage budgets related to platforms and projects, including submission costs, travel, and training.
Partner in product development to provide strategic guidance from exploratory phases through compliance and commercialization.
Represent Regulatory Affairs in business unit meetings and product reviews.
Understand and anticipate regulatory expectations, including changes in the landscape.
Manage communications and negotiations with regulatory agencies.
Assess the impact of studies and data on project outcomes.
Coordinate with Quality on recall strategies and audit responses.
Ensure consistent messaging in advertising, promotion, and sales training materials.
Develop and approve regulatory policies, goals, and reports.
Communicate internal Regulatory Procedures and policies.
Participate in due diligence and product acquisition teams.
Develop government relations strategies in partnership with Legal and Government Affairs.
Build relationships with regulators, stakeholders, and advocates to promote BD’s interests.
Qualifications:
Bachelor’s or advanced degree in biology, chemistry, engineering, or a related medical field with at least nine years of experience, or equivalent.
Preferred 10-15 years in the medical device industry, with at least 9 years in regulatory roles.
Deep knowledge of US, European, and international medical device regulations and standards.
Strong organizational, planning, and project management skills, with a focus on results.
Experience in continuous improvement, project management, product development, and design control.
Excellent project management and multitasking abilities.
Ability to adapt to change and handle risk and uncertainty.
Previous management experience.
Effective judgment and discretion within broad policies.
Proficiency in managing complex projects and ambiguity.
Self-motivated with excellent communication skills, including cross-cultural communication and negotiation with regulators.
Ability to interpret testing methods and statistics relevant to medical devices.
Knowledge of current and future policies, practices, trends, and technologies affecting the industry.
Additional preferred qualifications include an advanced degree, RAC certification, experience with Clinical Trial applications (US IDE), and experience with Medication Delivery and Combination Products.
Employment is contingent upon proof of COVID-19 vaccination or testing, where applicable, in accordance with company policies.
We prioritize
on-site collaboration
with a minimum of 4 days per week in the office to foster innovation and teamwork, while also supporting work-life balance.
Why Join Us?
At BD, your opinions and contributions are valued. We foster an inclusive, growth-oriented culture where you can develop your career and leave a meaningful legacy. Join us to help shape the future of health and make a difference in the world.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not discriminate based on race, religion, age, gender, or other protected statuses.
Required Skills
Details not specified.
Optional Skills
Details not specified.
Primary Work Location: USA, NJ - Franklin Lakes; Additional Locations: USA, UT - Salt Lake City.
Work Shift: On-site presence of at least 4 days per week.
Salary Range: $187,400 - $337,300 USD annually.
#J-18808-Ljbffr
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 Regulatory Affairs (RA) Director is responsible for managing and setting the strategic direction for the Medication Delivery and Vascular Care (MDVC) business platform within the Medication Delivery Solution Business Unit. The RA Director develops and implements regulatory strategies and submissions to support global marketing within the MDVC platform. This role involves collaboration with external contacts, US and international regulatory authorities, physician advisors, and industry specialists, requiring a comprehensive understanding of current and future policies, practices, trends, technology, and information affecting the organization.
Responsibilities:
Manage and direct work for multiple product families, RA projects, or a Regulatory Affairs platform.
Provide regulatory leadership for the respective platform, product families, or RA programs, managing RA managers and team members.
Recruit, develop, and manage RA professionals, ensuring regulatory milestones are met.
Oversee the management of RA professionals within the platform(s) or program(s), structuring projects for efficiency.
Develop managers and technical leaders through performance assessments, feedback, coaching, and mentoring.
Manage budgets related to platforms and projects, including submission costs, travel, and training.
Partner in product development to provide strategic guidance from exploratory phases through compliance and commercialization.
Represent Regulatory Affairs in business unit meetings and product reviews.
Understand and anticipate regulatory expectations, including changes in the landscape.
Manage communications and negotiations with regulatory agencies.
Assess the impact of studies and data on project outcomes.
Coordinate with Quality on recall strategies and audit responses.
Ensure consistent messaging in advertising, promotion, and sales training materials.
Develop and approve regulatory policies, goals, and reports.
Communicate internal Regulatory Procedures and policies.
Participate in due diligence and product acquisition teams.
Develop government relations strategies in partnership with Legal and Government Affairs.
Build relationships with regulators, stakeholders, and advocates to promote BD’s interests.
Qualifications:
Bachelor’s or advanced degree in biology, chemistry, engineering, or a related medical field with at least nine years of experience, or equivalent.
Preferred 10-15 years in the medical device industry, with at least 9 years in regulatory roles.
Deep knowledge of US, European, and international medical device regulations and standards.
Strong organizational, planning, and project management skills, with a focus on results.
Experience in continuous improvement, project management, product development, and design control.
Excellent project management and multitasking abilities.
Ability to adapt to change and handle risk and uncertainty.
Previous management experience.
Effective judgment and discretion within broad policies.
Proficiency in managing complex projects and ambiguity.
Self-motivated with excellent communication skills, including cross-cultural communication and negotiation with regulators.
Ability to interpret testing methods and statistics relevant to medical devices.
Knowledge of current and future policies, practices, trends, and technologies affecting the industry.
Additional preferred qualifications include an advanced degree, RAC certification, experience with Clinical Trial applications (US IDE), and experience with Medication Delivery and Combination Products.
Employment is contingent upon proof of COVID-19 vaccination or testing, where applicable, in accordance with company policies.
We prioritize
on-site collaboration
with a minimum of 4 days per week in the office to foster innovation and teamwork, while also supporting work-life balance.
Why Join Us?
At BD, your opinions and contributions are valued. We foster an inclusive, growth-oriented culture where you can develop your career and leave a meaningful legacy. Join us to help shape the future of health and make a difference in the world.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not discriminate based on race, religion, age, gender, or other protected statuses.
Required Skills
Details not specified.
Optional Skills
Details not specified.
Primary Work Location: USA, NJ - Franklin Lakes; Additional Locations: USA, UT - Salt Lake City.
Work Shift: On-site presence of at least 4 days per week.
Salary Range: $187,400 - $337,300 USD annually.
#J-18808-Ljbffr