Project Manager; Medical Devices III

Position: Project Manager (Medical Devices III)
Job Title: Project Manager (Medical Devices III)
Position Type: Contract
Location: Contract
Salary Range / Rate: $90/hr. to 130/hr.

Job Description:
We are seeking an experienced Project Manager (Consultant) to support the development, testing, and Premarket Approval (PMA) submission of a Class III long-term implantable medical device within the Implantable Device Unit (IDU). This role will provide end-to-end project leadership across design, verification and validation, manufacturing readiness, and regulatory submission activities. The Project Manager will partner closely with Device Development, Regulatory Affairs, Quality, Manufacturing, and external partners to ensure execution remains aligned with FDA expectations, design control requirements, and program timelines.

Responsibilities:
Project Execution & PMA Modular Submission:

• Lead integrated project plans focused on finalizing design control deliverables and completing PMA Modules, ensuring alignment with regulatory milestones and submission timelines.
• Drive execution of remaining verification and validation activities, ensuring traceability, documentation completeness, and readiness for regulatory review.

Regulatory & Quality Coordination:

• Partner with Regulatory Affairs and Quality to ensure all development, testing, and manufacturing activities comply with FDA PMA requirements, Design Controls (21 CFR 820), risk management (ISO 14971), and applicable standards.
• Support EU MDR transition activities, including gap assessments, documentation updates, and alignment of technical documentation with MDR expectations.

Verification & Validation Oversight:

• Provide oversight of device design verification (DV) activities, ensuring completion of DV testing, reporting, and cross-functional alignment to support PMA design control deliverables.
• Coordinate validation activities including human factors, bench testing, and clinical feedback incorporation, ensuring protocols and reports meet regulatory expectations.

Manufacturing & Clinical Supply Chain Management:

• Manage clinical product manufacturing supply chain activities as needed, including close day-to-day coordination with Contract Manufacturing Organizations (CMOs) to support clinical supply, process readiness, and PMA Modules deliverables.
• Coordinate cross-functional alignment between Manufacturing, Supply Chain, Quality, and external partners to manage schedules, risks, deviations, and readiness for inspections or regulatory review.

Risk, Issue & Change Management:

• Proactively identify, escalate, and mitigate technical, regulatory, quality, manufacturing, and supplier risks.
• Manage post-design-lock changes through formal change control processes, including impact assessments on PMA and MDR submissions.

Requirements:

• Bachelor's degree in Biomedical, Mechanical, Electrical Engineering, or a related technical discipline.
• 7-12+ years of experience managing complex medical device programs, preferably Class III implantable devices.
• Strong working knowledge of FDA PMA submissions, Design Controls, and regulated manufacturing environments.

• Demonstrated experience coordinating cross-functional and external teams in late-stage, submission-focused programs.

About Us:
Founded in 2009, Intelli Pro is a global leader in talent acquisition and HR solutions.

Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU.

Intelli Pro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, Intelli Pro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants.

Learn more about our commitment to diversity and inclusivity at

Compensation:
The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, Intelli Pro provides a comprehensive benefits package, all subject to eligibility.