Manager, MDS Regulatory Affairs Operations

Regulatory Jobs; Franklin Lakes (NJ); Sur place; USD 138 000 - 220 000; Plein temps

Avantages offerts par ce poste

Medical coverage

401(k) Plan

Paid time off

Life and AD&D insurance

Disability insurance

Educational assistance

Résumé du poste

BD is seeking a regulatory operations leader to drive governance of regulatory information systems and data, oversee PIM activities, and align regulatory data with business needs. You will lead EUDAMED readiness, NoC governance, and cross-functional initiatives across MDS to ensure compliance and efficiency.

The role requires 8+ years in regulatory affairs, expertise in RIM/PIM, and experience with digital transformation.

Qualifications

• Bachelor's degree in a relevant field and 8+ years in regulatory affairs or related medical device functions
• Experience with regulatory systems, data governance, and business process management
• Leadership of cross-functional initiatives and projects
• Strong knowledge of medical device regulatory processes and regulatory information management
• Experience with digital transformation, technology deployment, and organizational change

Responsabilités

• Lead regulatory operations for MDS Regulatory Affairs
• Govern regulatory information management systems and processes
• Oversee Product Information Management alignment of regulatory data with business needs
• Manage DEO governance and regulatory standards
• Lead EUDAMED implementation and readiness
• Govern NoC processes and regulatory assessments
• Establish data governance practices for regulatory data
• Develop regulatory metrics and dashboards for leadership
• Provide insights to Regulatory Affairs leadership for decisions
• Drive process improvement using BD Excellence and other methods
• Identify opportunities to improve efficiency, standardization, and automation
• Coordinate centralized regulatory initiatives across MDS
• Lead change management for new systems and processes
• Lead cross-functional projects supporting regulatory operations
• Identify risks and mitigation strategies
• Support business planning and governance reviews
• Ensure processes remain compliant and inspection-ready
• Foster accountability and collaboration

Connaissances

Regulatory affairs knowledge

Regulatory operations

Quality systems

Business operations

Program management

Digital transformation

Leadership

Cross-functional collaboration

Formation

Bachelor's degree in Science/Engineering/Regulatory Affairs/Business Administration/Information Systems

Master's degree or comparable experience

Regulatory Affairs Certification (RAC)

Lean Six Sigma certification

Project Management Professional (PMP) certification

Outils

Regulatory Information Management (RIM) systems

Product Information Management (PIM)

EUDAMED

Regulatory data governance

Description du poste

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.

Job Description

Key Responsibilities

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

Qualifications

• 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 Qualifications

• 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.

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

Other Well‑being Resources

• 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

Retirement and Financial Well‑being

• 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

Life Balance Programs

• 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

Other Life Balance Programs

• 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

Leave Programs

• Bereavement leaves
• Military leave
• Personal leave
• Family and Medical Leave (FML)
• Jury and Witness Duty Leave

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.

Required Skills

Optional Skills

Primary Work Location

USA NJ - Franklin Lakes

Work Shift

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.

Salary Range Information

$137,500.00 - $220,100.00 USD Annual