Project Manager (Medical Devices III)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

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