Overview In this role you lead cross-functional efforts to audit technical dossiers and bolster regulatory readiness for in-market clinical diagnostic products. You partner with Regulatory Affairs, R&D, Quality, Marketing, Medical Affairs and others to assess documentation completeness and compliance for global registrations and submissions. You drive gap analyses, remediation plans, and execution to ensure ongoing market access within a matrix organization. This position focuses on quality systems, design controls, and continuous improvement of regulatory documentation processes.
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, risk management files, labeling, and 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- Facilitate gap assessments to identify missing, outdated, incomplete, or non-compliant documentation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
- 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 milestones and follow up with owners to ensure deliverables are on time
- Maintain accurate project documentation, dashboards, and status reports for leadership
- Communicate project status, risks, mitigation plans, and key decisions to cross-functional leadership
- Ensure activities comply with quality systems, design control requirements, and regulatory expectations
- Support continuous improvement initiatives related to technical documentation, regulatory readiness, and project execution
- Apply project management best practices and tools to drive alignment and accountability
Key requirements- Bachelor's degree in a scientific, engineering, regulatory, or related discipline
- 3-5 years of project management experience in a regulated industry
- Experience in medical devices, IVD, biotechnology, life sciences, or related regulated environments
- Experience leading cross-functional initiatives with multiple stakeholders
- Working knowledge of product development documentation, design controls, quality systems, and regulatory submission processes
- Experience coordinating complex projects involving documentation review, compliance assessments, or remediation
- Familiarity with global regulatory frameworks applicable to medical devices and IVD products
- Experience supporting regulatory submissions, product registrations, or compliance programs is a plus
- PMP certification is a plus but not required
- Strong communication and presentation skills
- Facilitation and meeting leadership
- Analytical thinking and problem solving
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Word
