Regulatory Project Manager

Insight Global; San Diego (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Insight Global is seeking an experienced Project Manager to lead regulatory documentation and compliance initiatives for clinical diagnostic products. You will partner with Regulatory Affairs, R&D, Quality, Manufacturing, Medical Affairs, and Marketing to ensure DHFs and technical files are complete for global regulatory submissions.

The role thrives in highly regulated environments and involves driving cross-functional projects from planning through execution, with an emphasis on documentation

Qualifications

• 3+ years of project management experience in a regulated industry.
• Experience supporting Medical Device, Diagnostics (IVD), Biotechnology, Pharmaceutical, or Life Sciences products.
• Strong understanding of Design Controls, Quality Systems, Technical Documentation, Verification & Validation, Regulatory Processes.
• Experience leading cross-functional teams and managing competing priorities.
• Excellent communication and stakeholder management skills.

Responsibilities

• Lead regulatory, compliance, and technical documentation projects for clinical diagnostic products.
• Build and manage project plans, timelines, milestones, risks, and stakeholder communications.
• Coordinate reviews of DHFs, risk management documentation, verification & validation reports, technical files, and labeling documentation.
• Identify documentation gaps and drive remediation activities across multiple functional teams.
• Facilitate documentation audits and regulatory readiness efforts.
• Partner with Regulatory Affairs, Quality, R&D, Manufacturing, Medical Affairs, and Marketing teams.
• Lead project meetings and track action items through completion.
• Communicate project status, risks, and mitigation plans to leadership.
• Support continuous improvement initiatives related to compliance and documentation processes.

Skills

Project management

Regulatory affairs

Cross-functional leadership

Communication

Risk management

Education

Bachelor's degree in Engineering or Life Sciences or Regulatory Affairs

Tools

PLM systems

Document management systems

Job description

We're seeking an experienced Project Manager to lead regulatory documentation and compliance-focused initiatives supporting clinical diagnostic products. This role will partner closely with Regulatory Affairs, R&D, Quality, Manufacturing, Medical Affairs, and Marketing teams to ensure technical files are complete, compliant, and ready for global regulatory submissions and product sustainment activities.

This is an excellent opportunity for someone who thrives in highly regulated environments and enjoys driving complex cross-functional projects from planning through execution.

Responsibilities

• Lead regulatory, compliance, and technical documentation projects for clinical diagnostic products
• Build and manage project plans, timelines, milestones, risks, and stakeholder communications
• Coordinate reviews of Design History Files (DHFs), risk management documentation, verification & validation reports, technical files, and labeling documentation
• Identify documentation gaps and drive remediation activities across multiple functional teams
• Facilitate documentation audits and regulatory readiness efforts
• Partner with Regulatory Affairs, Quality, R&D, Manufacturing, Medical Affairs, and Marketing teams
• Lead project meetings and track action items through completion
• Communicate project status, risks, and mitigation plans to leadership
• Support continuous improvement initiatives related to compliance and documentation processes

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biology, Regulatory Affairs, or related field
• 3+ years of project management experience within a regulated industry
• Experience supporting Medical Device, Diagnostics (IVD), Biotechnology, Pharmaceutical, or Life Sciences products
• Strong understanding of:
• Design Controls
• Quality Systems
• Technical Documentation
• Verification & Validation
• Regulatory Processes
• Experience leading cross-functional teams and managing competing priorities
• Excellent communication and stakeholder management skills

Preferred Qualifications

• Regulatory submission experience
• Medical Device or IVD industry experience
• Documentation remediation or audit support experience
• PMP certification
• Experience with PLM or document management systems