Senior MDR Compliance Program Lead

Lancesoft; Lafayette (CO); On-site; USD 150,000 - 190,000; Full time

Job summary

Medtronic in Lafayette, CO and Mounds View, MN seeks a Principal Project Management Specialist to lead MDR implementation and compliance change-control programs for released products, coordinating across Regulatory Affairs, Quality, Engineering and Supply Chain.

You will translate regulatory and quality requirements into executable plans, align suppliers and OEMs, manage scope, budgets, and risks, and drive readiness reviews.

Qualifications

• Bachelor’s degree and 7+ years of relevant experience (or advanced degree with 5+ years).
• Degrees earned outside the United States must meet equivalency requirements.
• Experience leading complex cross-functional projects in medical devices or regulated environments.
• Strong ability to translate regulatory, quality, and business needs into executable plans.
• Direct experience coordinating with OEMs, contract manufacturers, or external suppliers.
• Proven skill in managing schedules, budgets, risks, dependencies, and governance.
• Excellent ability to influence, negotiate, and communicate across diverse teams without authority.
• Ability to work independently through ambiguity and changing priorities.

Responsibilities

• Lead multiple MDR implementation and compliance projects for released products from initiation to closure.
• Guide cross-functional teams across Regulatory Affairs, Quality, Engineering, Manufacturing, Operations, and Supply Chain.
• Develop integrated plans linking technical deliverables with regulatory and quality requirements.
• Collaborate with OEMs for MDR transition planning and readiness actions.
• Coordinate released-product changes across components, suppliers, processes, and quality systems.
• Manage scope, schedules, budgets, resources, risks, assumptions, dependencies, decisions, governance, and reporting.
• Lead meetings and readiness reviews, maintaining decisions and action ownership.
• Advance PMO practices through lessons learned and data-driven coaching.

Skills

Regulatory program management

Cross-functional leadership

MDR/Regulatory experience

Budget and schedule management

Influence without authority

Problem solving under ambiguity

Quality systems knowledge

OEM/contract-manufacturer coordination

Executive-level communication

Risk management

Education

Bachelor’s degree + 7+ years

Advanced degree (MS/PhD) + 5+ years

International degree equivalency

Certifications: PMP/Lean/Six Sigma

Job description

Medtronic in Lafayette, CO and Mounds View, MN seeks a Principal Project Management Specialist to lead MDR implementation and compliance change-control programs for released products, coordinating across Regulatory Affairs, Quality, Engineering and Supply Chain.

You will translate regulatory and quality requirements into executable plans, align suppliers and OEMs, manage scope, budgets, and risks, and drive readiness reviews.