Manager, Regulatory Affairs- Strategic Alliances
- Location
- Lafayette, Colorado, United States of America
- Work mode
- On-site
- Employment type
- Full-time
About the job
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.
- Maintain forward-looking registration roadmaps and forecasts that align partner demand with regional capacity, product readiness, and business priorities.
- 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.
- Monitor performance and use lessons learned to improve forecasting, planning accuracy, responsiveness, and partner experience.
- 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.
- Identify recurring requests and develop standardized content, guidance, or self-service solutions that improve efficiency while protecting compliance and confidential information.
- 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.
- Escalate significant compliance, contractual, market-access, timeline, or business-continuity risks to the appropriate governance body.
- 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.
- Promote an inclusive, accountable, responsive, and continuous-improvement culture focused on partner commitments, patient access, and compliant execution.
- 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.
- Ability to communicate and influence effectively with internal leaders, regional teams, technical experts, and external business partners.
- 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 AskHR@medtronic.com . 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 holid
From SAU Medtronic Saudi Arabia LLC's careers page (Workday), checked 30 Oct 2026.
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Posted 29 Oct 2026 · checked 30 Oct 2026 · Report this job