Project Manager, Regulatory Compliance Specialist, Quality Engineering

Job title:

Program Manager (Program integrator)

Location:

Thousand Oaks, CA 91320 (Hybrid)

Must be local to ATO will be onsite 1x/week on average

Duration: 12+ Months (possibility of extension)

• Support cross-functional coordination for medical device and combination product development programs from development through commercialization.
• Assist in the creation and maintenance of integrated project plans, timelines, milestone trackers, and action logs.
• Partner with team members across engineering, quality, regulatory, clinical, manufacturing, supply chain, and other functions to support aligned execution.
• Help coordinate core team meetings and program reviews by preparing agendas, capturing decisions, documenting action items, and following up on commitments.
• Track project progress against timelines and milestones and elevate risks, delays, or cross-functional issues as appropriate.
• Support preparation of project dashboards, status reports, presentations, and milestone review materials for team and leadership meetings.
• Help maintain program documentation and support readiness for design reviews, phase gates, verification, validation, design transfer, and launch activities.
• Assist with risk, issue, assumption, and change tracking to support program visibility and execution.
• Support coordination of selected activities with external partners, suppliers, and contract manufacturers, as applicable.
• Contribute to process improvement efforts related to project management tools, team routines, templates, and reporting practices.
• Help ensure project activities remain aligned with applicable quality system, design control, and regulatory expectations with guidance from functional experts.

• Doctorate degree or
• Master's degree and 2 years of experience or
• Bachelor's degree and 4 years of experience or
• Associate's degree and 8 years of experience or
• High school diploma / GED and 10 years of experience

• Project planning and tracking
  - Ability to maintain integrated plans, schedules, milestones, action logs, risks, and status reporting.
• Cross-functional coordination and communication
  - Ability to work effectively across engineering, quality, regulatory, clinical, manufacturing, and supply chain teams in a matrixed environment.
• Strong organization and follow-through
  - Ability to manage multiple priorities, document decisions and actions accuratly, identify issues early, and ensure commitments are completed.

• Maintaining project plans and trackers-updating timelines, milestones, action logs, assumptions, risks, issues, and changes.
• Coordinating cross-functional teams across engineering, quality, regulatory, clinical, manufacturing, supply chain, and other functions.
• Organizing team meetings and program reviews-preparing agendas, documenting decisions, assigning action items, and following up on commitments.
• Monitoring project progress and identifying schedule delays, dependencies, resource concerns, or cross-functional issues that need escalation.
• Preparing status materials, including dashboards, presentations, milestone summaries, and leadership updates.
• Managing program documentation and helping teams prepare for design reviews, phase gates, verification, validation, design transfer, and launch.
• Coordinating with suppliers and external partners when their work affects the program schedule or deliverables.
• Improving project-management processes, such as templates, reporting methods, team routines, and planning tools.
• Supporting compliance by helping ensure activities and documentation remain aligned with design-control, quality-system, and regulatory expectations.

• Networking, career experience

Yes

• Does not meet the basic qualifications for education and relevant experience.
• Poor organization or follow-through, including difficulty managing deadlines, actions, or multiple priorities.
• Weak cross-functional communication or inability to work effectively in a matrixed team.
• Passive project-management style, such as failing to identify risks, elevate delays, or hold owners accountable.
• Low attention to detail, particularly in project plans, meeting records, status reports, and regulated documentation.

Interview with 3-4 people. A mix of Teams and In-Person.