Manager, Regulatory Affairs- Strategic Alliances

We anticipate the application window for this opening will close on - 12 Nov 2026

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 Manager, Regulatory Affairs - Strategic Alliances leads regulatory support for ACM strategic alliance partners and serves as a primary regulatory interface across the partnership lifecycle. This leader translates commercial agreements and partner product roadmaps into global regulatory strategies and executable registration plans; coordinates execution through product design and regional Regulatory Affairs teams; enables accurate and timely partner communications; supports partner documentation requests and health authority questions; and drives resolution of complex integration, change, and market-access challenges. The Manager leads one direct report while delivering outcomes through broad cross-functional and regional influence. Demonstrated expertise in project or program management is highly valued in this role.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

Partner Regulatory Strategy & Registration Planning

• Serve as the named Regulatory Affairs point of contact for assigned strategic alliance partners, developing trusted relationships and maintaining continuity of agreement context, product history, and regulatory commitments.

• Translate partnership agreements, commercial priorities, product roadmaps, technical integration plans, and launch objectives into global regulatory strategies, milestones, dependencies, and executable registration plans.

• Clarify Medtronic and partner regulatory roles, deliverables, decision rights, documentation expectations, and escalation pathways for each program and market.

• Identify regulatory risks, sequencing constraints, and market-access opportunities early enough to influence product, evidence, investment, integration, and launch decisions.

• Maintain forward-looking registration roadmaps and forecasts that align partner demand with regional capacity, product readiness, and business priorities.

Global Execution, Monitoring & Partner Updates

• Drive execution of agreed registration plans through product design and regional Regulatory Affairs teams and cross-functional partners, without duplicating regional submission ownership.

• Establish operating rhythms, trackers, milestones, dashboards, and governance forums that provide clear visibility to progress, upcoming decisions, risks, and overdue actions.

• Provide partners with accurate, timely, and audience-appropriate updates on registration status, constraints, decisions, and recovery plans.

• Anticipate execution gaps, escalate issues with clear options and recommendations, and coordinate accountable action plans through closure.

• Monitor performance and use lessons learned to improve forecasting, planning accuracy, responsiveness, and partner experience.

Partner Portal, Documentation & Health Authority Support

• Own the Regulatory Affairs intake, triage, prioritization, and coordination of partner portal requests for registration documentation and regulatory information.

• Coordinate with product, regional, quality, clinical, engineering, operations, legal, and other subject matter experts to provide complete, consistent, controlled, and timely responses.

• Support partners as they pursue global registrations, including responding to questions from health authorities and coordinating supplemental documentation or technical clarification.

• Maintain request records, documentation traceability, partner-specific knowledge, and appropriate access controls within the portal and related systems.

• Identify recurring requests and develop standardized content, guidance, or self-service solutions that improve efficiency while protecting compliance and confidential information.

Issue Resolution, Change Assessment & Integration Support

• Lead cross-functional troubleshooting when partner registrations or integrations encounter barriers, ambiguity, or misalignment.

• Coordinate resolution of issues involving product release readiness, system configuration, regulatory data, documentation inconsistencies, submission dependencies, and regional requirements.

• Assess or coordinate regulatory impact assessments for product and process changes, partner product change notifications, evolving regulations and standards, and sustaining activities.

• Facilitate fact-based decisions across Medtronic, partner, and regional stakeholders; document decisions, owners, actions, and residual risks.

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