Engineering Project Manager - Regulatory Readiness

MillenniumSoft Inc; San Diego (CA); On-site; USD 90,000 - 100,000; Full time

Job summary

MillenniumSoft Inc. in San Diego, CA is seeking an Engineering Project Manager to lead cross-functional regulatory readiness work for in-market diagnostic products.

The role partners with Regulatory Affairs, R&D, Quality, and Marketing to ensure complete, compliant technical documentation for global registrations and re-registrations. The successful candidate will coordinate reviews, identify gaps, and drive remediation plans in a matrix organization, supporting market access and lifecycle

Qualifications

• Bachelor's degree in a scientific, engineering, regulatory, or related discipline.
• 3–5 years of project management experience in a regulated industry.
• Experience with medical devices, IVD, biotech, or life sciences is preferred.
• Knowledge of design controls, quality systems, and regulatory submissions.

Responsibilities

• Lead cross-functional technical dossier audit projects for regulatory re-registration.
• Develop and maintain integrated project plans with milestones.
• Coordinate reviews of DHFs, V&V docs, risk files, and labeling.
• Assess documentation readiness for regulatory submissions with stakeholders.
• Identify gaps and develop remediation plans with SMEs.
• Manage risks, dependencies, and issues with proactive planning.
• Schedule and facilitate team meetings and working sessions.
• Record decisions, action items, and project updates.
• Monitor progress against milestones; ensure timely deliverables.
• Maintain dashboards and status reports for leadership.
• Communicate status, risks, and decisions to cross-functional leads.
• Ensure activities comply with quality systems and design controls.
• Support continuous improvement of regulatory readiness processes.
• Apply PM best practices to drive alignment and accountability.

Skills

Project planning

Organization

Execution

Meeting facilitation

Communication

Risk management

Cross-functional leadership

Stakeholder management

Education

Bachelor's degree in scientific/engineering/regulatory discipline

Tools

Microsoft Project

Excel

PowerPoint

PM tools (PMP friendly)

Job description

MillenniumSoft Inc. in San Diego, CA is seeking an Engineering Project Manager to lead cross-functional regulatory readiness work for in-market diagnostic products.

The role partners with Regulatory Affairs, R&D, Quality, and Marketing to ensure complete, compliant technical documentation for global registrations and re-registrations. The successful candidate will coordinate reviews, identify gaps, and drive remediation plans in a matrix organization, supporting market access and lifecycle