Engineering ProgramProject Management Onsite9Req Exp in Regulated or Medical Device Industry)

Job Title - Engineering Program/Project Management

Job Location - San Diego California

Duration: 12 Months

Job Description -

Pay Rate $45 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.

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• Facilitate gap assessments to identify missing outdated incomplete or non-compliant documentation.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

• Bachelors 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.