Regulatory Project Manager at Insight Global Regulatory Project Manager at Insight Global in Poway, California Posted in 1 day ago.

Type:

full-time 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 Risk Management 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 Global regulatory experience