Project Manager III (PO&T)

Location: Remote to hybrid (U.S.); Boston area strongly preferred
Experience Level: 712+ years
Industry: Medical Devices Class III Long-Term Implantable Devices / Drug Delivery
Degree Requirements: Bachelors degree in Engineering or related technical discipline required; advanced degree preferred

About the Role and Job Summary

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.

Key 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, ocumentation 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.

Qualifications Required
Bachelors degree in Biomedical, Mechanical, Electrical Engineering, or a related technical discipline.
712+ 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.

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



Core Competencies
Project planning and execution
Budget and cost control
Schedule and Product management
Stakeholder and vendor management
Strong analytical, organizational, and communication skills