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.
Key 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.
Required Qualifications
- 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 and their impact on product development and compliance activities.
- Demonstrated experience using Smartsheet for project scheduling, resource planning, workflow management, and reporting.
- Proven 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.
Preferred 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.
Key Competencies
- Leadership and stakeholder management
- Strategic planning and execution
- Regulatory and compliance awareness
- Analytical problem solving
- Executive communication and reporting
- Risk management
- Time and resource management
Pay: $54.00 - $58.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Work Location: Remote
