Engineering Program/Project Management - Onsite9Req Exp in Regulated or Medical Device Industry)

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• Facilitate gap assessments to identify missing, outdated, incomplete, or non-compliant documentation.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

Job Title - Engineering Program/Project Management

Job Location - San Diego, California

Duration: 12 Months

Job Description -

The Project Manager will lead cross-functional initiatives focused on technical dossier audits and regulatory readiness activities for in-market clinical diagnostic products. This role will partner closely with Regulatory Affairs, R&D, Quality, Marketing, Medical Affairs, and other stakeholders to assess the completeness and compliance of technical documentation required to support global product registrations, re-registrations, and regulatory submissions.

The successful candidate will coordinate the systematic review of technical files and supporting design documentation, facilitate identification of compliance gaps, develop remediation plans with subject matter experts, and drive execution to ensure products meet applicable regulatory requirements. This individual will work effectively within a matrix organization, providing project leadership, risk management, planning, and communication to support regulatory compliance objectives and continued market access.

Experience working in a regulated medical device, in vitro diagnostics (IVD), biotechnology, or life sciences environment is highly desirable.

Pay Rate $45 on site Position Summary

Job 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.

Minimum Qualifications

Education and Experience

• 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, in vitro diagnostics (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.
• Experience coordinating complex projects involving documentation review, compliance assessments, or remediation activities preferred.
• 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.

Knowledge, Skills, And Abilities

• Strong project planning, organization, and execution skills.
• Ability to manage multiple projects and priorities simultaneously.
• Excellent meeting facilitation, written communication, and presentation skills.
• Strong analytical, problem-solving, and risk management capabilities.
• Demonstrated ability to influence and drive accountability in a matrix organization.
• Proven ability to track and manage action items, dependencies, and project deliverables.
• Detail-oriented with a commitment to quality and compliance.
• Proficient with Microsoft Office applications including Excel, PowerPoint, Word, and Project.
• Experience with project management, document management, or product lifecycle management tools is preferred.
• Demonstrated ability to effectively communicate with technical, regulatory, and business stakeholders.