Operations Lead

Key Responsibilities

• Lead the design, documentation, and maintenance of clear and practical processes, procedures, and workflows suitable for a regulated environment.
• Engage with cross-functional teams to assess current state operations, identify process gaps and inefficiencies, and develop structured, scalable solutions that improve execution.
• Interface with global regulatory teams to support projects, process improvement initiatives and provide project management to regulatory submission and regulatory intelligence activities.
• Lead cross-functional regulatory and operational initiatives from initiation through completion, including scope definition, timeline development, risk identification, and milestone tracking.
• Cookordination activities across Regulatory Affairs, Clinical Development, Quality, R&D, global teams and other functions to ensure alignment with regulatory submission timelines and business priorities.
• Develop and maintain high-quality process documentation and project artifacts that are controlled, reusable, and aligned with regulatory standards.
• Utilize internal systems including Enterprise Resource Planning (ERP) platforms, SharePoint, and document management tools to organize and manage project and operational information.
• Coordinate with Regulatory Affairs SMEs to ensure operational processes effectively support submission readiness and compliance activities.
• Support the development and standardization of tools/templates that enhance visibility, consistency, and efficiency across projects.
• Identify systems to improve the overall efficiency of processes within Premarket RA, ensuring alignment with applicable standards and regulations (e.g., 21 CFR Part 820/QMSR, ISO 13485, EU MDR).
• Perform additional duties and responsibilities as required by leadership.

Position Requirements

• Ability to interpret procedures and identify areas for process improvement leading to the development and support of documentation to maintain standard work.
• Strong facilitation skills, including leading meetings and guiding discussions toward concrete outcomes.
• Ability to interact with different global and regional teams with varying priorities and styles.
• Working knowledge of regulated environments or the ability to quickly learn regulatory requirements.
• Strong organizational skills and attention to both detail and overall workflow.
• Ability to work independently and as part of a larger project team.
• Demonstrated capability to take ownership of projects.
• Clear written and verbal communication skills.

Benefits

• Competitive compensation range: $71,000 - $85,000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Educational reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.