Medical Device Regulatory Program Manager

MillenniumSoft Inc; San Diego (CA); On-site; USD 55,000 - 69,000; Full time

Job summary

MillenniumSoft Inc. is seeking an Engineering Program/Project Manager in San Diego to lead cross-functional initiatives focused on regulatory readiness for in-market diagnostic products. You will coordinate audits, remediation plans, and risk management to ensure submissions and market access.

A strong background in regulated medical devices or IVD is highly desirable. The role requires collaboration with Regulatory Affairs, R&D, Quality, Marketing, and Medical Affairs, with a focus on

Qualifications

• Bachelor's degree in a scientific, engineering, regulatory, or related discipline.
• Minimum of 3-5 years of experience in project management within a regulated industry.
• Experience in medical devices, IVD, biotechnology, life sciences, or related regulated environments.

Responsibilities

• Lead cross-functional technical dossier audit projects supporting regulatory re-registration and product sustainment initiatives.
• Develop and maintain integrated project plans, timelines, milestones, and progress tracking mechanisms.
• Coordinate reviews of technical documentation, including design history files, verification and validation documentation, risk management files, labeling, and other 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• Facilitate gap assessments to identify missing, outdated, incomplete, or non-compliant documentation.

Skills

Project planning

Risk management

Cross-functional coordination

Stakeholder communication

Meeting facilitation

Education

Bachelor's degree (scientific/engineering/regulatory)

Tools

Microsoft Project

Document management tools

Job description

MillenniumSoft Inc. is seeking an Engineering Program/Project Manager in San Diego to lead cross-functional initiatives focused on regulatory readiness for in-market diagnostic products. You will coordinate audits, remediation plans, and risk management to ensure submissions and market access.

A strong background in regulated medical devices or IVD is highly desirable. The role requires collaboration with Regulatory Affairs, R&D, Quality, Marketing, and Medical Affairs, with a focus on