Regulatory Project Manager

Insight Global

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

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Vacancy posted 2 days ago

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