Project Manager - EU MDR

Job Title:

Project Manager

Job Description

We are seeking an experienced Project Manager to lead cross-functional projects within a regulated medical device environment. The ideal candidate will have a strong understanding of European Union Medical Device Regulation (EU MDR 2017/745) requirements and demonstrated experience managing complex projects from initiation through completion. This role requires strong organizational, communication, and reporting skills, including advanced proficiency with Smartsheet for project planning, portfolio management, and executive dashboard development.

Responsibilities

+ Lead and manage multiple projects and programs supporting medical device development, regulatory compliance, remediation, and product lifecycle initiatives.

+ Develop and maintain detailed project plans, schedules, milestones, risks, and resource allocations within Smartsheet.

+ Create and maintain executive-level Smartsheet dashboards for program reviews, status reporting, KPI tracking, and portfolio visibility.

+ Coordinate cross-functional teams including Regulatory Affairs, Quality, R&D, Clinical, Manufacturing, Supply Chain, and Marketing.

+ Ensure project deliverables align with EU MDR requirements, timelines, and organizational objectives.

+ Facilitate project governance meetings and communicate project status, risks, issues, and mitigation plans to stakeholders and leadership.

+ Monitor project budgets, schedules, and resource utilization to ensure successful project execution.

+ Identify and manage project risks and dependencies, implementing corrective actions when necessary.

+ Drive accountability across project teams and ensure timely completion of deliverables.

+ Support inspection readiness, regulatory compliance activities, and continuous process improvement initiatives.

Essential Skills

+ Bachelor's degree in Engineering, Life Sciences, Business, or a related field.

+ 5+ years of project management experience, preferably within the medical device, life sciences, or regulated healthcare industry.

+ Strong working knowledge of EU MDR (Medical Device Regulation 2017/745) requirements.

+ Demonstrated experience using Smartsheet for project scheduling, resource planning, workflow management, and reporting.

+ Ability to build and manage Smartsheet dashboards for executive and program review meetings.

+ Experience leading cross-functional teams and managing complex projects with multiple stakeholders.

+ Strong risk management, planning, organizational, and communication skills.

+ Proficiency with Microsoft Office Suite, including Excel, PowerPoint, and Teams.

Additional

Skills & Qualifications

+ Project Management Professional (PMP) certification preferred.

+

Experience with medical device remediation, regulatory compliance projects, or CE Marking activities.

+ Familiarity with Quality Management Systems (QMS), design controls, risk management, and regulatory submissions.

+ Experience working in Agile, Waterfall, or hybrid project management environments.

Work Environment

The role involves working in a regulated medical device environment where advanced tools like Smartsheet are used for project management and executive reporting. The position requires coordination with various departments such as Regulatory Affairs, Quality, R&D, and more, necessitating strong communication and leadership skills.

Job Type & Location

This is a Contract position based out of Greenwood Village, CO.

Pay and Benefits

The pay range for this position is $50.00 - $60.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

- Medical, dental & vision
- Critical Illness, Accident, and Hospital - 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability
- Health Spending Account (HSA) - Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Final date to receive…