Engineering Project Manager - Onsite (Req Exp in Regulated or medical Device Industry)

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

pay rate:45hr on site Position Summary

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.

• 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.

Job Title -

Engineering Project Manager

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.

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.