MDR Compliance Project Manager (Engineering)

JobDiva, Inc.; Lafayette (CO); On-site; USD 83,000 - 96,000; Full time

Benefits offered by this job

Travel up to 25%

Job summary

Primary Talent Partners has a new contract opening for a Project Manager (Engineering) in Lafayette, CO. This 14-month W2 contract focuses on MDR implementation and compliance change-control for released products, coordinating Regulatory Affairs, Quality, Engineering, and more.

Travel up to 25% across the US is required. The role demands a strong PM background, prioritizing disciplined program management and stakeholder influence without direct authority to ensure compliant product availability

Qualifications

• Bachelor's degree (or advanced degree) with equivalent requirements for non-US degrees.
• 7+ years leading complex cross-functional projects in regulated environments preferred.
• Experience translating regulatory, quality, and technical requirements into executable plans.

Responsibilities

• Lead multiple MDR implementation and compliance projects from initiation to closure.
• Coordinate cross-functional teams across Regulatory Affairs, Quality, Engineering, Manufacturing, Operations, and Supply Chain.
• Develop integrated plans connecting technical deliverables with regulatory and quality requirements.
• Collaborate with OEMs and contract manufacturers to establish milestones, decision rights, and readiness expectations.
• Manage scope, schedules, budgets, risks, and governance; report with actionable options.

Skills

Project management

Cross-functional leadership

Regulatory awareness

Education

Bachelor's degree

Advanced degree (preferred)

Job description

Primary Talent Partners has a new contract opening for a Project Manager (Engineering) in Lafayette, CO. This 14-month W2 contract focuses on MDR implementation and compliance change-control for released products, coordinating Regulatory Affairs, Quality, Engineering, and more.

Travel up to 25% across the US is required. The role demands a strong PM background, prioritizing disciplined program management and stakeholder influence without direct authority to ensure compliant product availability