Manager, MDS Regulatory Affairs Operations
BD
A complete application in a minute
Tailored resume and cover letter, ready to send.
Job summary
BD is hiring for a senior regulatory operations leader to support MDS Regulatory Affairs. You will own governance for RIM systems, lead PIM activities, and drive coordination of regulatory data across the business.
The role requires extensive experience with regulatory data governance and transformation initiatives. Remote work is limited with strong emphasis on on-site collaboration; you will engage cross-functional teams to ensure compliance, efficiency, and readiness for global regulatory
Qualifications
- 8+ years of experience in Regulatory Affairs or related medical device functions.
- Demonstrated experience with regulatory systems, regulatory data governance, and business process management.
- Experience leading cross-functional initiatives and projects.
Responsibilities
- Lead regulatory business operations activities supporting the MDS Regulatory Affairs organization.
- Serve as governance lead for Regulatory Information Management (RIM) systems and processes.
- Lead all aspects of Product Information Management (PIM) activities and ensure data alignment with business needs.
- Oversee DEO governance, maintenance, and regulatory standards guidance.
- Drive EUDAMED implementation, governance, compliance, and readiness activities.
- Develop regulatory metrics, dashboards, and performance indicators.
Skills
Education
Tools
Job description
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.
- 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.
- 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.
- 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.
- 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.
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.
Optional Skills
USA NJ - Franklin Lakes
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.
$137,500.00 - $220,100.00 USD Annual
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
