Associate Director, MDS Regulatory Affairs Systems & Operations

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.

Qualifications Required

• 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 escalate 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.

Additional information

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.

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.
• 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 $183,800.00 - $294,100.00 USD Annual