US_Project Manager III (PO&T)

Position: Project Manager III
Location: 140 6th St, Cambridge, MA 02142
Duration: 6-month contract (with potential for extension or conversion to permanent)
Compensation: $ 124.61 - 138.45 /hr (W2)
Benefits: Weekly pay, medical, dental, and vision coverage
Work Model: Remote to hybrid within the U.S. (Boston area strongly preferred)


Position Overview
We are seeking an experienced Project Manager Consultant to support the development, testing, and PMA submission activities for a Class III long-term implantable medical device within the Implantable Device Unit (IDU). This individual will provide end-to-end leadership across device development, verification and validation, manufacturing readiness, and regulatory submission efforts.
The Project Manager will collaborate closely with cross-functional teams including Device Development, Regulatory Affairs, Quality, Manufacturing, Supply Chain, and external partners to ensure all program deliverables align with FDA expectations, design control requirements, and overall project timelines.
 
Key Responsibilities
Project Execution & PMA Submission

• Lead integrated project plans focused on completion of design control deliverables and PMA modules while ensuring alignment with submission timelines and regulatory milestones.
• Drive execution of verification and validation activities, ensuring traceability, documentation accuracy, and inspection readiness.
• Monitor project schedules, dependencies, deliverables, and overall program execution.

Regulatory & Quality Coordination

• Partner with Regulatory Affairs and Quality teams to ensure compliance with FDA PMA requirements, Design Controls (21 CFR 820), ISO 14971 risk management standards, and applicable medical device regulations.
• Support EU MDR transition activities including documentation updates, gap assessments, and alignment of technical files with MDR expectations.
• Ensure all project documentation and testing activities meet regulatory and quality standards.

Verification & Validation Oversight

• Oversee device verification activities including DV testing execution, reporting, and cross-functional coordination.
• Coordinate validation activities such as bench testing, human factors studies, and clinical feedback integration.
• Ensure protocols, reports, and deliverables are completed in accordance with regulatory expectations.

Manufacturing & Supply Chain Management

• Manage clinical manufacturing and supply chain activities, including coordination with Contract Manufacturing Organizations (CMOs).
• Partner with Manufacturing, Quality, Supply Chain, and external vendors to support clinical supply readiness and PMA deliverables.
• Track manufacturing risks, schedules, deviations, and inspection readiness activities.

Risk & Change Management

• Identify, assess, and mitigate technical, regulatory, manufacturing, supplier, and quality risks throughout the project lifecycle.
• Manage post-design-lock changes through formal change control processes, including impact assessments related to PMA and MDR submissions.

Required Qualifications

• Bachelor’s degree in biomedical, Mechanical, Electrical Engineering, or related technical field.
• 7–12+ years of project management experience within regulated medical device environments.
• Strong experience supporting Class III implantable medical device programs.
• Working knowledge of FDA PMA submissions, Design Controls, and regulated manufacturing processes.
• Proven ability to manage cross-functional teams and external partners in submission-focused programs.

 
Preferred Qualifications

• Experience supporting PMA completion activities and regulatory interactions.
• Experience with EU MDR transition initiatives for late-stage or legacy medical devices.
• Hands-on experience managing CMOs and clinical manufacturing supply chains.

 
Core Competencies

• Project planning and execution
• Budget and cost management
• Schedule and scope management
• Stakeholder and vendor coordination
• Risk assessment and mitigation
• Strong communication, analytical, and organizational skills

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