Project Manager, Regulatory

Masimo • Irvine, CA

80d • $90,000 - $125,000

About The Position

The Project Manager, Regulatory Affairs will be responsible for planning, coordinating, and executing projects that support regulatory and quality compliance across Masimo’s medical device portfolio. These projects may include regulatory submissions, remediation activities, compliance with international regulations (e.g., EU MDR, FDA), quality system enhancements, and audit readiness initiatives. The ideal candidate will have experience managing projects in a regulated environment, excellent organizational and communication skills, and the ability to work effectively across multiple functions such as Regulatory Affairs, Quality, Engineering, Clinical, and Operations. This is a hands-on project management role focused on coordination, execution, and timely delivery.

Requirements

• Minimum 3–5 years of project management experience in the medical device, pharmaceutical, or regulated industry
• Strong understanding of regulatory and quality processes (e.g., FDA 21 CFR 820, ISO 13485, EU MDR)
• Demonstrated ability to manage multiple concurrent projects and cross-functional teams
• Proficiency with project management tools (MS Project, Smartsheet, Monday.com, or similar)
• Excellent written and verbal communication skills with attention to detail and clarity
• Strong problem-solving, organization, and prioritization skills
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Ability to work both independently and collaboratively in a dynamic, fast-paced environment
• Excellent prioritizing, organizational, and interpersonal skills
• A detail-oriented individual, with a 'can do' attitude, and the ability to work in a team environment, as well as individually (with minimal supervision)

Nice To Haves

• Experience with global regulatory submissions or compliance programs (e.g., FDA, EU, Health Canada)
• Familiarity with Quality Management Systems (QMS), risk management (ISO 14971), CAPA, and design control processes
• Experience supporting regulatory audits, inspections, or Notified Body reviews
• Certification in Project Management (PMP) or Regulatory Affairs (RAC) preferred
• Experience working within a medical device Class II or Class III environment
• Experience in patient monitor systems, hospital-based products, software or electronic device products

Responsibilities

• Lead and manage regulatory and quality-related projects, including global regulatory submissions, compliance initiatives, and quality system improvements
• Develop detailed project plans, including timelines, deliverables, dependencies, and risk mitigation strategies
• Coordinate cross-functional teams (Regulatory, Quality, R&D, Clinical, Manufacturing) to ensure project milestones are met
• Support preparation and maintenance of regulatory documentation, including technical files, labeling and promotional/ advertisement materials, product registrations, and audit materials
• Track progress, manage changes to scope or schedule, and communicate project updates to management and stakeholders
• Maintain dashboards and reports to provide visibility into project status and deliverables
• Facilitate effective communication between technical teams and regulatory/quality leadership
• Assist with preparation for internal and external audits, regulatory inspections, and certification activities
• Support continuous improvement initiatives related to documentation, processes, and systems in RA/QA
• Manage document reviews, version control, and change management activities related to assigned projects
• Provide project team leadership as necessary
• Performs other duties or special projects as assigned

Benefits

• Medical, Dental, Vision, Life/AD&D, Disability Insurance
• 401(k)
• Vacation, Sick, Holiday
• Paid Maternity Leave
• Flexible Spending Accounts
• Voluntary Accident, Critical Illness, Hospital, Long-Term Care
• Employee Assistance Program
• Pet Insurance
• On-site Wellness Clinic
• Fitness Center and Cafe

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees