Regulatory Project Manager, Medical Devices & Dossiers

Lancesoft; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Lancesoft is seeking a Project Manager in San Diego, CA to lead cross-functional initiatives focused on regulatory readiness for in-market clinical diagnostic products. You will coordinate audits of technical dossiers and collaborate with Regulatory Affairs, R&D, Quality, Marketing, Medical Affairs, and other stakeholders to ensure documentation supports global product registrations and submissions.

This role requires effective risk management, planning, and communication within a matrix

Qualifications

• Bachelor's degree in a scientific, engineering, regulatory, or related discipline.
• 3–5 years of project management experience in a regulated industry.
• Experience with medical devices, IVD, biotechnology, or life sciences is highly desirable.
• PMI PMP certification is a plus.

Responsibilities

• Lead cross-functional technical dossier audit projects supporting regulatory re-registration and product sustainment initiatives.
• Develop and maintain integrated project plans, timelines, milestones, and progress tracking mechanisms.
• Coordinate reviews of technical documentation, including design history files, verification and validation documentation, risk management files, labeling, and other regulatory deliverables.
• Partner with Regulatory Affairs, R&D, Quality, Medical Affairs, Manufacturing, and Marketing to assess documentation readiness for regulatory submissions.
• Facilitate gap assessments to identify missing, outdated, incomplete, or non-compliant documentation.
• Drive development and execution of remediation plans to address identified gaps and ensure submission readiness.
• Manage project risks, dependencies, and issues through proactive planning and escalation when needed.
• Schedule, organize, and facilitate team meetings, reviews, and working sessions.
• Record and publish meeting minutes, decisions, action items, and key project updates.
• Monitor progress against project milestones and follow up with functional owners to ensure timely completion of deliverables.
• Maintain accurate project documentation, dashboards, and status reports for leadership and stakeholders.
• Communicate project status, risks, mitigation plans, and key decisions to cross-functional leadership teams.
• Ensure project activities are conducted in compliance with applicable quality systems, design control requirements, and regulatory expectations.
• Support continuous improvement initiatives related to technical documentation processes, regulatory readiness, and project execution.
• Apply project management best practices and tools to drive alignment, accountability, and project success.

Skills

Cross-functional leadership

Regulatory awareness

Project management

Risk management

Stakeholder communication

Education

Bachelor's degree in a scientific, engineering, regulatory, or related discipline

Tools

Microsoft Office (Excel, PowerPoint, Word)

MS Project

Document management systems

Job description

Lancesoft is seeking a Project Manager in San Diego, CA to lead cross-functional initiatives focused on regulatory readiness for in-market clinical diagnostic products. You will coordinate audits of technical dossiers and collaborate with Regulatory Affairs, R&D, Quality, Marketing, Medical Affairs, and other stakeholders to ensure documentation supports global product registrations and submissions.

This role requires effective risk management, planning, and communication within a matrix