BD
Job Description Summary This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. This position participates on cross‑functional teams, leads the development of global regulatory strategies, authors regulatory submissions, leads interactions with regulatory agencies/notified bodies, reviews design control documents and product labeling, and evaluates proposed device changes. This position interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.
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.
Job Responsibilities
Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met
Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market
Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements
Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval
Leads interactions with FDA, EU notified bodies, and other regulatory agencies on submissions and other issues
Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications
Communicates changes to global regions and supports preparation of global notifications as needed
Understands fundamental global regulatory requirements and different regulatory pathways
Stays informed of new regulations and changes to existing regulations and communicates to project teams
Identifies and communicates appropriately quantified risks and mitigation strategies associated with regulatory changes to partners
Maintains regulatory databases and systems
Supports regulatory body audits, CAPAs, and other compliance activities
Reviews advertising and promotional material
Participates in claims development strategy
Leads training related to areas of expertise
Mentors other regulatory colleagues
Minimum Requirements
Bachelor’s degree or higher
6–8 years’ Regulatory Affairs experience in the medical device industry
Experience leading communications with FDA, EU notified bodies, and other regulatory agencies
Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions
Proven experience owning and managing the end-to-end process of regulatory approvals/clearances
Experience with product development processes and design controls
Excellent written and verbal communication skills
Strong negotiation skills
Problem‑solving and analytical skills
Detail‑oriented with organizational skills to manage multiple tasks
Ability to work in a team‑oriented, fast‑paced environment
Proficiency in Microsoft Office tools
Preferred Qualifications
Master’s degree in Regulatory Affairs
Regulatory Affairs Professional Society (RAPS) certification
Bachelor’s degree specifically in a scientific discipline
Experience mentoring other regulatory colleagues
Comprehensive understanding of global medical device regulations, with in-depth knowledge of US and EU requirements
Subject matter expertise in regulatory affairs
Ability to be effective in complex projects with ambiguity and rapid change
Physical Demands This position is in an office environment and may require the incumbent to sit, stand and perform general office functions. The incumbent may also be required to move up to twenty‑five pounds occasionally.
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.
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.
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.
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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.
Job Responsibilities
Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met
Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market
Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements
Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval
Leads interactions with FDA, EU notified bodies, and other regulatory agencies on submissions and other issues
Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications
Communicates changes to global regions and supports preparation of global notifications as needed
Understands fundamental global regulatory requirements and different regulatory pathways
Stays informed of new regulations and changes to existing regulations and communicates to project teams
Identifies and communicates appropriately quantified risks and mitigation strategies associated with regulatory changes to partners
Maintains regulatory databases and systems
Supports regulatory body audits, CAPAs, and other compliance activities
Reviews advertising and promotional material
Participates in claims development strategy
Leads training related to areas of expertise
Mentors other regulatory colleagues
Minimum Requirements
Bachelor’s degree or higher
6–8 years’ Regulatory Affairs experience in the medical device industry
Experience leading communications with FDA, EU notified bodies, and other regulatory agencies
Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions
Proven experience owning and managing the end-to-end process of regulatory approvals/clearances
Experience with product development processes and design controls
Excellent written and verbal communication skills
Strong negotiation skills
Problem‑solving and analytical skills
Detail‑oriented with organizational skills to manage multiple tasks
Ability to work in a team‑oriented, fast‑paced environment
Proficiency in Microsoft Office tools
Preferred Qualifications
Master’s degree in Regulatory Affairs
Regulatory Affairs Professional Society (RAPS) certification
Bachelor’s degree specifically in a scientific discipline
Experience mentoring other regulatory colleagues
Comprehensive understanding of global medical device regulations, with in-depth knowledge of US and EU requirements
Subject matter expertise in regulatory affairs
Ability to be effective in complex projects with ambiguity and rapid change
Physical Demands This position is in an office environment and may require the incumbent to sit, stand and perform general office functions. The incumbent may also be required to move up to twenty‑five pounds occasionally.
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.
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.
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.
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