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Staff Specialist, Regulatory Affairs
role at
BD
This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. It 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. It interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.
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
Mentor 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? At BD, you’ll discover a culture that values your opinions and contributions, encourages you to bring your authentic self to work, and supports learning, growth and personal excellence.
Equal Opportunity Statement: 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.
Location: USA UT - Salt Lake City, BAS
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Staff Specialist, Regulatory Affairs
role at
BD
This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. It 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. It interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.
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
Mentor 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? At BD, you’ll discover a culture that values your opinions and contributions, encourages you to bring your authentic self to work, and supports learning, growth and personal excellence.
Equal Opportunity Statement: 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.
Location: USA UT - Salt Lake City, BAS
#J-18808-Ljbffr