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Principal Project Management Specialist — Medical Device Compliance

LanceSoft Inc · Lafayette, CO · Compliance PMO

Compensation

$70 – $80 /hr

Employment type

Full-time

Work setting

On-site

Location

Lafayette, CO

Schedule

Day shift

Posted

Travel

Required

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Job overview

The Principal Project Management Specialist role is onsite in Lafayette, CO; the posting also lists Mounds View, MN as a possible location. Pay is $70–$80 per hour, and travel is up to 25%, primarily in the US. The role is within the Compliance PMO and leads EU Medical Device Regulation implementation and compliance change-control projects for released products. The specialist coordinates regulatory, quality, engineering, operations, supply chain, manufacturing sites, OEMs, contract manufacturers, and suppliers to turn compliance requirements into executable plans. The role contributes to compliant product availability and continuity of supply through disciplined project planning, risk management, operational readiness, and change execution.

What you'll do

  • Lead multiple MDR implementation and compliance change-control projects from initiation through closure
  • guide cross-functional teams
  • develop integrated plans connecting technical deliverables, regulatory and quality requirements, supplier activities, and operational constraints
  • coordinate OEM transition planning
  • manage released-product changes across components, suppliers, manufacturing processes, specifications, packaging, labeling, quality systems, and regulatory requirements
  • manage scope, schedules, budgets, resources, risks, dependencies, decisions, governance, and reporting
  • lead meetings and readiness reviews
  • communicate updates
  • advance portfolio priorities and PMO practices through lessons learned, data insights, coaching, and influence.

What we're looking for

Skills & competencies
principal project management specialist
lafayette co
lancesoft
$70–$80/hr
medical device compliance
eu mdr
change control
compliance pmo
cross-functional projects
supply chain
travel up to 25%
released products
Work arrangement
  • Weekend coverage required

Why this role

Travel up to 25%, primarily in the US; role focuses on EU MDR implementation and compliance change control for released medical-device products.

About the employer

LanceSoft Inc is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.

Additional details

Industry sector
54
Industry
Administrative Management and General Management Consulting Services
Occupation code
13-1082.00
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