Project Manager, Regulatory Compliance Specialist, Operations Management

Project Manager

This role is an excellent opportunity for an experienced Project Manager to lead complex, cross-functional initiatives within a regulated medical device environment. You will oversee projects from initiation through completion, ensuring alignment with European Union Medical Device Regulation (EU MDR 2017/745) requirements and organizational objectives. The position requires strong organizational, communication, and reporting skills, with advanced proficiency in Smartsheet for project planning, portfolio management, and executive dashboard development.

You will collaborate with diverse teams across the product lifecycle to drive regulatory compliance, remediation, and continuous improvement.

• 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 using 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 to ensure cohesive project execution.
• Ensure project deliverables align with EU MDR requirements, established timelines, and broader organizational objectives.
• Facilitate project governance meetings and clearly communicate project status, risks, issues, and mitigation plans to stakeholders and leadership.
• Monitor project budgets, schedules, and resource utilization to ensure successful and efficient project delivery.
• Identify, assess, and manage project risks and dependencies, implementing corrective actions when necessary.
• Drive accountability across project teams and ensure timely completion of project deliverables.
• Support inspection readiness activities and contribute to regulatory compliance initiatives and continuous process improvement.

• Bachelor's degree in Engineering, Life Sciences, Business, or a related field.
• At least 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.
• Ability to build and manage Smartsheet dashboards for executive and program review meetings.
• Proven 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.
• Leadership and stakeholder management capabilities.
• Strategic planning and execution skills.
• Regulatory and compliance awareness in a highly regulated environment.
• Analytical problem-solving skills.
• Executive-level communication and reporting skills.
• Effective time and resource management.

• 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.

You will work in a highly regulated medical device environment that emphasizes quality, compliance, and patient safety. The role involves close collaboration with cross-functional teams…