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. Application Deadline This position is anticipated to close on Sep 22, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. 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