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New · posted Oct 14

Becton Dickinson · Medical Devices

Manager, MDS Regulatory Affairs Operations

  • Franklin Lakes, NJ
  • On-site
  • Full-time
  • Manager
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EmploymentFull-time
Deadline

Open until filled

What you need

Required Skills

Optional Skills

  • Bachelor's degree in Science, Engineering, Regulatory Affairs, Business Administration, Information Systems, or related discipline.
  • 8+ years of experience in Regulatory Affairs, Regulatory Operations, Quality Systems, Business Operations, Program Management, or related medical device functions.
  • Demonstrated experience with regulatory systems, regulatory data governance, and business process management.
  • Experience leading initiatives and cross-functional projects.
  • Strong knowledge of medical device regulatory processes and regulatory information management.
  • Experience supporting digital transformation, technology deployment, and organizational change.

Preferred Qualificationsnice to have

  • A Master's degree or comparable experience.
  • Regulatory Affairs Certification (RAC).
  • Lean Six Sigma certification.
  • Project Management Professional (PMP) certification.
  • Experience with regulatory systems, EUDAMED, product data governance, and enterprise regulatory technology initiatives.

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. For most roles, 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. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.

What you'll do

  1. Lead regulatory business operations activities supporting the MDS Regulatory Affairs organization.
  2. Serve as business owner and governance lead for Regulatory Information Management (RIM) systems and processes.
  3. Lead all aspects of Product Information Management (PIM) activities and ensure alignment of regulatory data with business requirements.
  4. Lead Documents of External Origin (DEO), including governance, maintenance, communication, and assessment of regulatory standards and guidance documents.
  5. Lead EUDAMED implementation, governance, compliance, and operational readiness activities.
  6. Lead Global Notification of Change (NoC) governance and associated regulatory assessment processes.
  7. Establish and maintain RIM regulatory data governance practices to ensure accuracy, consistency, and compliance.
  8. Develop and maintain regulatory metrics, dashboards, reporting tools, and operational performance indicators.
  9. Provide operational insights and recommendations to Regulatory Affairs leadership to support informed decision-making.
  10. Lead process improvement initiatives using BD Excellence and other continuous improvement methodologies.
  11. Identify, prioritize, and implement opportunities to improve efficiency, standardization, automation, and scalability of regulatory processes.
  12. Serve as the primary MDS liaison to Central Regulatory Affairs organizations.
  13. Coordinate implementation of central Regulatory Affairs initiatives and technologies across MDS.
  14. Lead change management global notifications, communication, training, and adoption activities associated with new systems, technologies, and business processes.
  15. Lead cross-functional projects supporting regulatory operations, business transformation, and organizational effectiveness.
  16. Identify operational risks, develop mitigation strategies, and escalate issues as appropriate.
  17. Support business planning, resource planning, governance reviews, and strategic operational initiatives.
  18. Ensure regulatory operational processes remain compliant, inspection-ready, and aligned with corporate requirements.
  19. Drive a culture of accountability, collaboration, operational excellence, and continuous improvement.

Pay and benefits

$137,500 – $220,100 a year

Employer provided

Salary Range Information

$137,500.00 - $220,100.00 USD Annual

Health and Well-being Benefits

  • Medical coverage

  • Health Savings Accounts

  • Flexible Spending Accounts

  • Dental coverage

  • Vision coverage

  • Hospital Care Insurance

  • Critical Illness Insurance

  • Accidental Injury Insurance

  • Life and AD&D insurance

  • Short-term disability coverage

  • Long-term disability insurance

  • Long-term care with life insurance

  • Anxiety management program

  • Wellness incentives

  • Sleep improvement program

  • Diabetes management program

  • Virtual physical therapy

  • Emotional/mental health support programs

  • Weight management programs

  • Gastrointestinal health program

  • Substance use management program

  • Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit

  • BD 401(k) Plan

  • BD Deferred Compensation and Restoration Plan

  • 529 College Savings Plan

  • Financial counseling

  • Baxter Credit Union (BCU)

  • Daily Pay

  • College financial aid and application guidance

  • Paid time off (PTO), including all required State leaves

  • Educational assistance/tuition reimbursement

  • MetLife Legal Plan

  • Group auto and home insurance

  • Pet insurance

  • Commuter benefits

  • Discounts on products and services

  • Academic Achievement Scholarship

  • Service Recognition Awards

  • Employer matching donation

  • Workplace accommodations

  • Adoption assistance

  • Backup day care and eldercare

  • Support for neurodivergent adults, children, and caregivers

  • Caregiving assistance for elderly and special needs individuals

  • Employee Assistance Program (EAP)

  • Paid Parental Leave

  • Support for fertility, birthing, postpartum, and age-related hormonal changes

  • Bereavement leaves

  • Military leave

  • Personal leave

  • Family and Medical Leave (FML)

  • Jury and Witness Duty Leave

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.

Where you'll work

Franklin Lakes, NJOn-siteOpen in Maps (opens in a new tab)

More jobs in Franklin Lakes, NJ

Working conditions

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Primary Work Location

USA NJ - Franklin Lakes

Well over a hundred smiling BD associates in team shirts gathered outside BD's plant in the Dominican Republic

From the posting

About BD

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.

BD company page · 78 open roles
Equal opportunity, accessibility and legal noticesBecton Dickinson's statements, word for word

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.

Job intelligence

The context around this role

Live data · October 14, 2026

Salary intelligence

How the pay compares

This roleEmployer provided

$137,500 to $220,100 a year
Annual base pay
Annual base payLowMedianHigh
This role$137,500—$220,100

This role: Becton Dickinson's own published range.

Career trajectory

Where this role sits in Regulatory Operations

The general path across 23 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not BD's own promotion track.

  1. Earlier

    Associate & Specialist

    Often: Intern · Associate Regulatory Affairs Specialist

    $78K median10 open
  2. One step back

    Senior & Principal

    Often: SR Coordinator, Regulatory Submission Operations

  3. This role

    Manager

    Often: Manager, MDS Regulatory Affairs Operations · Manager, Regulatory Operations

  4. Next step

    Director

    Often: Associate Director, Global Regulatory Project Management and Strategic Planning · Associate Director, Regulatory Data Management & Intelligence

    $201K median7 open

Skills DNA

What this role leans on

How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 3 linesLab testing and methods: 2 linesDocumentation and SOPs: 1 lineQuality systems and risk: 3 linesData and digital systems: 2 linesCollaboration and leadership: 13 linesGMPLab testingDocumentationQuality systemsData systemsTeamwork
  • Collaboration and leadership13
  • GMP and compliance3
  • Quality systems and risk3
  • Lab testing and methods2
  • Data and digital systems2
  • Documentation and SOPs1

Company hiring pulse

BD on Regulatory Jobs

78
Open roles
69
Distinct roles
17
Locations

By discipline

  • Quality61 78%
  • Regulatory15 19%
  • Compliance & Safety2 3%

By level

  • Senior & Principal40 51%
  • Associate & Specialist24 31%
  • Manager11 14%
See all 78 BD roles

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Similar Regulatory Operations roles elsewhere

Manager, MDS Regulatory Affairs Operations at BD

Open until filled. $138K–$220K a year, employer provided.

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