Regulatory Dossier & Program Lead – Medical Devices

Planet Pharma; San Diego (CA); On-site; USD 48,000 - 62,000; Full time

Job summary

Planet Pharma seeks a Project Manager to lead cross-functional initiatives focused on technical dossier audits and regulatory readiness for in-market clinical diagnostic products. You will partner with Regulatory Affairs, R&D, Quality, Marketing, Medical Affairs, and other stakeholders to assess documentation for global registrations and submissions.

The role coordinates systematic reviews of technical files, identifies compliance gaps, and drives remediation plans to ensure timely submission

Qualifications

• Bachelor’s degree in a scientific, engineering, regulatory, or related discipline.
• Minimum of 3–5 years of experience in project management within a regulated industry.
• Experience in medical devices, IVD, biotechnology, life sciences, or related regulated environments.
• PM leadership across multiple stakeholders and priorities.

Responsibilities

• Lead cross-functional technical dossier audit projects supporting regulatory re-registration and product sustainment.
• Develop and maintain integrated project plans, timelines, milestones, and progress tracking.
• Coordinate reviews of technical documentation including design history files, verification/validation docs, risk management files, labeling, and regulatory deliverables.
• Partner with Regulatory Affairs, R&D, Quality, Medical Affairs, Manufacturing, and Marketing to assess documentation readiness for submissions.
• Facilitate gap assessments to identify missing, outdated, incomplete, or non-compliant documentation.
• Drive remediation plans to address identified gaps and ensure submission readiness.

Skills

Project management

Cross-functional leadership

Regulatory readiness

Planning and scheduling

Communication

Education

Bachelor’s degree in science/engineering/regulatory

Tools

Microsoft Office (Excel, PowerPoint, Word, Project)

Job description

Planet Pharma seeks a Project Manager to lead cross-functional initiatives focused on technical dossier audits and regulatory readiness for in-market clinical diagnostic products. You will partner with Regulatory Affairs, R&D, Quality, Marketing, Medical Affairs, and other stakeholders to assess documentation for global registrations and submissions.

The role coordinates systematic reviews of technical files, identifies compliance gaps, and drives remediation plans to ensure timely submission