Manager, Regulatory Affairs- Strategic Alliances

Medtronic • Lafayette, CO

6d

About The Position

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

The manager owns partner-facing regulatory planning and coordination, including clarifying roles, deliverables, decision rights, documentation expectations, and escalation pathways. The role maintains registration roadmaps and forecasts, monitors execution and risks, provides partner updates, and supports registration documentation requests through partner portals and related systems. It also coordinates cross-functional issue resolution, regulatory impact assessments, and fact-based decisions on product, process, and partner changes. The position builds relationships across internal functions and partner organizations, communicates complex topics to varied audiences, and promotes accountable, inclusive, compliant execution focused on partner commitments and patient access.

Requirements

• Baccalaureate degree in science, engineering, regulatory affairs, or a related discipline and at least 5 years of relevant experience, including 3 or more years of leadership experience through direct management and/or significant mentorship or advisory responsibility; or an advanced degree and at least 3 years of relevant experience, including 3 or more 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.
• For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• Unrestricted U.S. work authorization at the time of hire and for the duration of employment is required for this role; sponsorship is offered exclusively for Principal-level roles and above.

Nice To Haves

• 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.
• Demonstrated expertise in project or program management.

Responsibilities

• Serve as the named Regulatory Affairs point of contact for assigned strategic alliance partners and maintain 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 registration plans.
• Clarify 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 aligned with partner demand, regional capacity, product readiness, and business priorities.
• Drive execution of 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 to provide visibility into progress, decisions, risks, and overdue actions.
• Provide partners with accurate, timely, audience-appropriate updates on registration status, constraints, decisions, and recovery plans.
• Anticipate execution gaps, escalate issues with options and recommendations, and coordinate accountable action plans through closure.
• Monitor performance and apply lessons learned to improve forecasting, planning accuracy, responsiveness, and partner experience.
• Own 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 pursuing global registrations, including responding to health authority questions and coordinating supplemental documentation or technical clarification.
• Maintain request records, documentation traceability, partner-specific knowledge, and appropriate access controls within portals and related systems.
• Identify recurring requests and develop standardized content, guidance, or self-service solutions 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 and document decisions, owners, actions, and residual risks.
• Escalate significant compliance, contractual, market-access, timeline, or business-continuity risks to the appropriate governance body.
• Lead, coach, and develop one direct report, establishing responsibilities, priorities, performance expectations, and development objectives.
• Allocate work between the leader and direct report based on partner complexity, risk, business priority, and development needs.
• Build relationships with Strategic Alliance Sales, Quality, R&D, Operations, Marketing, Legal, Supply Chain, and partner organizations.
• Communicate complex regulatory topics clearly to 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.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive through the Medtronic Incentive Plan (MIP).
• For regular employees working 20 or more 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 or reimbursement; and the Simple Steps global well-being program.
• For all regular employees: incentive plans, 401(k) plan with 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).
• Temporary employees are eligible for paid sick time as required by applicable state law and the Employee Stock Purchase Plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager