Regulatory Medical Device Program Manager

MillenniumSoft Inc; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

MillenniumSoft Inc. in San Diego, CA seeks a Project Manager to lead cross-functional initiatives focused on regulatory readiness for in-market diagnostic products.

You will coordinate audits of technical files, drive remediation plans, and ensure compliance with design controls and quality systems while aligning with Regulatory Affairs, R&D, and Marketing. The ideal candidate has 3–5 years in a regulated industry, with strong documentation, risk management, and stakeholder communication skills

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 working in medical devices, IVD, biotechnology, life sciences, or related regulated environments.
• Demonstrated experience leading cross-functional initiatives involving multiple stakeholders and competing priorities.
• Working knowledge of product development documentation, design controls, quality systems, and regulatory submission processes.
• Familiarity with global regulatory frameworks applicable to medical devices and IVD products is preferred.
• Experience supporting regulatory submissions, product registrations, or compliance programs is a plus.
• Project Management Professional (PMP) certification is a plus but not required.

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• Facilitate gap assessments to identify missing, outdated, incomplete, or non-compliant documentation.
• 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 when needed.
• 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 project milestones and follow up with functional owners to ensure timely completion of deliverables.
• Maintain accurate project documentation, dashboards, and status reports for leadership and stakeholders.
• Communicate project status, risks, mitigation plans, and key decisions to cross-functional leadership teams.
• Ensure project activities are conducted in compliance with applicable quality systems, design control requirements, and regulatory expectations.
• Support continuous improvement initiatives related to technical documentation processes, regulatory readiness, and project execution.
• Apply project management best practices and tools to drive alignment, accountability, and project success.

Skills

Project management

Regulatory knowledge

Cross-functional leadership

Documentation review

Risk management

Stakeholder communication

Regulatory submissions

Quality systems

MS Office

Education

Bachelor's degree in science/engineering/regulatory

PMP certification (preferred)

Tools

Microsoft Project

Microsoft Office

Document management systems

Job description

MillenniumSoft Inc. in San Diego, CA seeks a Project Manager to lead cross-functional initiatives focused on regulatory readiness for in-market diagnostic products.

You will coordinate audits of technical files, drive remediation plans, and ensure compliance with design controls and quality systems while aligning with Regulatory Affairs, R&D, and Marketing. The ideal candidate has 3–5 years in a regulated industry, with strong documentation, risk management, and stakeholder communication skills