Associate Director, MDS Regulatory Affairs Systems & Operations

Becton, Dickinson and Company; Franklin Lakes (NJ); On-site; USD 184,000 - 294,000; Full time

Benefits offered by this job

Health & well-being benefits

401(k) retirement program

Paid time off & holidays

Career development

Job summary

Becton, Dickinson and Company seeks an experienced Regulatory Affairs leader to own the MDS RA systems and data, drive governance, and ensure audit readiness across multiple platforms and regions. You will manage RIM/RIMSYS, PIM, EUDAMED, and UDI workflows, partnering with cross-functional teams to maintain lifecycle compliance and effective change control.

Ideal candidates bring 8+ years in regulated affairs, strong writing skills, and the ability to influence without direct authority.

Qualifications

• Bachelor's degree in life sciences, engineering, regulatory affairs, quality, information systems, or a related discipline.
• 8+ years progressive experience in medical device Regulatory Affairs, Quality, regulatory operations, or regulated systems/process management.
• Demonstrated experience leading regulatory or quality processes across multiple functions, platforms, sites, or regions.
• Working knowledge of medical device QMS expectations, audit readiness, document control, change control, regulatory data, UDI, and lifecycle compliance.
• Experience with regulated system governance, business process ownership, requirements definition, validation or testing support, data quality, and user adoption.
• Strong written communication skills, including authoring procedures, work instructions, governance documents, training materials, and executive updates.
• Ability to lead through influence, make risk-based decisions, manage competing priorities, and elevate issues clearly.

Responsibilities

• Provide overall leadership and accountability for MDS RA systems, regulatory data, and enabling capabilities, establishing clear ownership and governance.
• Own the MDS RA procedure framework, including generation, approval, implementation, and harmonization across platforms.
• Serve as the MDS Audit Process Owner with evidence visibility, escalation and corrective-action oversight.
• Establish governance for MDS RA training and capability enablement, including onboarding, job aids, and training-effectiveness evaluation.
• Provide governance for RIM/RIMSYS, PIM, EUDAMED, uDI databases, PEGA workflows and related reporting tools.
• Oversee regulatory-system data quality, workflow governance, system health, reporting, and issue escalation.
• Own the end-to-end MDS Notification of Change operating framework and regulatory operations support for change control.
• Global eUMDR transition governance, readiness, risks, decisions, and SSOT data alignment across platforms.

Skills

Regulatory leadership

Regulatory data management

Audit readiness

Document control

Change control

RIM/RIMSYS

PIM

EUDAMED

UDI

PEGA RSM/DEO

RA governance

Training governance

Cross-functional collaboration

Written communication

Education

Bachelor's degree in life sciences/engineering/regulatory affairs

Master's degree or RAC/ASQ CMQ/OE certification

Regulatory affairs certification (RAC)

Tools

PEGA

SharePoint

Power BI

Job description

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.

Key Responsibilities

• Provide overall leadership and accountability for MDS RA systems, operational processes, regulatory data, and enabling capabilities, establishing clear ownership, governance, decision rights, controls, and continuity coverage.
• Own the MDS RA procedure framework, including procedure generation, alignment, approval, implementation, maintenance, portfolio governance, review cadence, and harmonization across MDS platforms where appropriate.
• Serve as the MDS RA Audit Process Owner, maintaining a consistent audit-readiness and support model with clear evidence visibility, ownership, escalation, observation follow-up, and corrective-action oversight.
• Establish governance for MDS RA training and capability enablement, including role-based onboarding, job aids, reference materials, change enablement, completion monitoring, and training-effectiveness evaluation.
• Provide business process ownership and functional governance for RIM/RIMSYS, PIM, EUDAMED, eIPRRA, PEGA RSM/DEO, RAIBot, and related reporting tools, including system access, role governance, onboarding, support, segregation of duties, and continuity coverage.
• Oversee regulatory-system data quality, workflow governance, system health, reporting, performance metrics, issue escalation, and the responsible use of automation and digital capabilities.
• Own MDS governance for Documentation of External Origin, regulations, standards, and associated regulatory intelligence, ensuring applicable requirements are inventoried, assessed, assigned, tracked, escalated, and communicated through controlled processes.
• Provide governance for Global UDI and MDS product data, including PIM, Basic UDI-DI, EUDAMED, GUDID, Swissdamed, and other applicable jurisdictional databases, with appropriate controls for new-jurisdiction implementation, verification, remediation, and compliance tracking.
• Provide MDS oversight of FDA annual establishment registration and device listing, including accountability, record accuracy, completion visibility, supporting evidence, and escalation of identified gaps.
• Own the end-to-end MDS Notification of Change operating framework and regulatory operations support for change control, ensuring Where Registered reports and GTIN triggers provide reliable inputs to regulatory planning and implementation decisions and that required actions are tracked through closure.
• Provide MDS RA leadership for the Global eUMDR transition, including governance of readiness, dependencies, risks, decisions, implementation visibility, and SSOT data alignment across Platform RA and International RA, while working cross-functionally with Supply Chain, Manufacturing, Quality, and other applicable stakeholders to ensure inventory transition planning is aligned with regulatory approvals, manufacturing implementation, market requirements, and business readiness.

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.

Qualifications

• Bachelor's degree in life sciences, engineering, regulatory affairs, quality, information systems, or a related discipline.
• 8 or more years progressive experience in medical device Regulatory Affairs, Quality, regulatory operations, or regulated systems/process management.
• Demonstrated experience leading regulatory or quality processes across multiple functions, platforms, sites, or regions.
• Working knowledge of medical device QMS expectations, audit readiness, document control, change control, regulatory data, UDI, and lifecycle compliance.
• Experience with regulated system governance, business process ownership, requirements definition, validation or testing support, data quality, and user adoption.
• Strong written communication skills, including authoring procedures, work instructions, governance documents, training materials, and executive updates.
• Ability to lead through influence, make risk-based decisions, manage competing priorities, and elevate issues clearly.

Preferred

• Master's degree or recognized regulatory/qualit y certification such as RAC, ASQ CQA, or ASQ CMQ/OE.
• Experience with RIM/RIMSYS, PIM, EUDAMED, GUDID or other UDI databases, PEGA-based workflows, eIPRRA, SharePoint, Power BI, or comparable regulated platforms.
• Experience supporting MDSAP, notified body, FDA, or internal quality audits.
• Experience applying Lean, Kaizen, structured problem solving, or comparable operational-excellence methods.
• Experience managing distributed teams, shared-service partners, vendors, or matrixed project resources.

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.

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 Additional Locations 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.

Benefits may include

• Health & Well-being: Medical, dental, vision, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs.
• Retirement & Financial Well-being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources.
• Work-Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs.
• Leave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave.

Additional details regarding benefits and well-being programs can be found in Our Commitment to You.

Salary Range Information $183,800.00 - $294,100.00 USD Annual

We are the MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond.

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.