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. 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)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected]. ‌ Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$120,800.00 - $181,200.00 ‌ This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]

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