Manager, Regulatory Affairs- Strategic Alliances

Job description

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 LifeThe 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. Escalate significant compliance, contractual, market-access, timeline, or business-continuity risks to the appropriate governance body. People & Stakeholder Leadership Lead, coach, and develop one direct report, establishing clear responsibilities, priorities, performance expectations, and development objectives. Allocate work between the leader and direct report based on partner complexity, risk, business priority, and capability development needs. Build strong relationships with Strategic Alliance Sales, Quality, R&D, Operations, Marketing, Legal, Supply Chain, and partner organizations. Communicate complex regulatory topics clearly across executive, partner, regional, and technical audiences and influence outcomes without relying on formal authority. Promote an inclusive, accountable, responsive, and continuous-improvement culture focused on partner commitments, patient access, and compliant execution. Must Have: Minimum Requirements Baccalaureate degree in science, engineering, regulatory affairs, or a related discipline and a minimum of 5 years of relevant experience, including 3+ years of leadership experience demonstrated through direct management and/or significant mentorship or advisory responsibility; or an advanced degree with a minimum of 3 years of relevant experience, including 3+ years of leadership experience. Demonstrated medical device regulatory experience supporting global registrations, product lifecycle activities, product changes, or market-access programs. Experience leading complex, cross-functional programs in a regulated, global, and matrixed environment. Experience translating strategy into structured plans, milestones, governance, risk management, and consistent execution. Ability to communicate and influence effectively with internal leaders, regional teams, technical experts, and external business partners. Nice to Have Advanced degree in science, engineering, regulatory affairs, business, law, or a related discipline. Experience supporting OEM, distributor, licensing, co-development, integration, or other strategic alliance business models. Experience developing global regulatory strategies and coordinating registrations across multiple international markets. Experience managing partner portals, request-management processes, controlled documentation, regulatory information systems, dashboards, or workflow tools. Experience assessing product changes, product change notifications, system or configuration changes, standards transitions, and documentation discrepancies. Working knowledge of design controls, product release, quality systems, labeling, and post-market regulatory obligations. Strong business acumen, customer orientation, negotiation, conflict resolution, presentation, and executive communication skills. Demonstrated success developing talent and improving team operating mechanisms. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)