Director, Regulatory Affairs Operations

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Director of Regulatory Affairs Operations is a member of the ACM Regulatory Affairs Leadership Team and leads the multidisciplinary capabilities that create the operating backbone for consistent, scalable, and compliant regulatory execution. This role is accountable for traditional regulatory affairs operations as well as specialty activities including radiofrequency registrations, OEM market access and broader business development regulatory work, portfolio phase outs, and regulatory compliance programs. The Director translates business priorities into operating plans and disciplined execution while leading approximately seven direct reports and influencing broadly across a global matrixed organization.

• •Create and execute the RA Operations strategy, operating model, and roadmap aligned with ACM and enterprise Regulatory Affairs priorities.
• •Own and continuously improve the systems, processes, data governance, tools, and workflows that enable regulatory execution across the product lifecycle, including regulatory information management, product lifecycle management, dashboards, and planning tools.
• •Lead simplification, standardization, automation, artificial intelligence enablement, and scalable service delivery initiatives that improve speed, quality, compliance, and organizational capacity.
• •Assess complex operational risks and bottlenecks, set priorities, make timely decisions, and drive sustainable solutions actions across the function.

• •Provide strategic and operational leadership for radiofrequency regulatory

• •Lead end-to-end regulatory stewardship for OEM devices, including deal assessment, agreement content, registration planning and execution, product release readiness, and ongoing lifecycle obligations.
• •Serve as the regulatory lead for broader BD&L activities, including due diligence, risk assessment, integration planning, transition of regulatory ownership, and handoff to steady-state teams.
• •Build effective regulatory-to-regulatory relationships with external partners and establish clear governance, deliverables, escalation pathways, and performance expectations.
• •Identify regulatory risks, obligations, and value-creation opportunities early enough to influence deal structure, investment decisions, integration plans, and market access commitments.

• •Lead regulatory compliance programs and governance across ACM RA, including regulatory intelligence, standards transitions, audit readiness, quality system procedures, and compliance monitoring.
• •Provide oversight and coordination for regulatory actions and signals, including field action-related regulatory support, CAPAs, health hazard assessments, inspection observations, and other compliance commitments, in partnership with Quality and business leaders.
• •Translate evolving global

• •Lead the regulatory execution for portfolio rationalization and planned phase outs of the ACM portfolio, establishing governance, milestones, resources, risks, and decision rights.
• •Oversee market-by-market registration withdrawal, cancellation, transfer, or maintenance plans in alignment with commercial, quality, operations, supply chain, legal, and regional requirements.
• •Ensure accurate transition and disposition of regulatory records and systems data, clear ownership of residual obligations, and completion of post-market and end-of-life commitments.
• •Provide transparent progress reporting, risk escalation, and cross-functional coordination to enable an orderly exit while protecting patients, compliance, and business continuity.

• •Lead, coach, and develop a diverse team of professionals.
• •Set a clear vision, roles, priorities, performance expectations, and development plans; build succession strength and an inclusive, accountable, high-performing culture.
• •Determine resource allocation across competing priorities and build workforce and capability plans that support current execution and future needs.
• •Communicate complex regulatory and operational topics with clarity across executive, cross-functional, and individual-contributor audiences; use strong written, presentation, and influencing skills to align stakeholders and accelerate decisions.
• •Develop du