Senior PMA Program Manager — Medical Devices

Ipro Networks Pte. Ltd.; Cambridge (MA); On-site; USD 124,000 - 179,000; Part time

Job summary

IntelliPro seeks an experienced Project Manager (Consultant) to oversee PMA submissions for a Class III implantable device. Lead end-to-end design control, verification and validation, and manufacturing readiness across diverse teams.

Collaborate with Regulatory Affairs, Quality, Manufacturing, and external partners to align with FDA expectations, risk management, and project timelines. This contract role requires extensive program leadership in late-stage submissions and MDR considerations.

Qualifications

• Bachelor's degree in Biomedical, Mechanical, or Electrical Engineering required.
• 7–12+ years of experience in 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.

Responsibilities

• Lead PMA modular submission planning and finalize design control deliverables with regulatory milestones.
• Drive verification and validation activities, ensuring traceability and regulatory readiness.
• Coordinate Regulatory Affairs and Quality to ensure compliance with FDA PMA requirements and Design Controls (21 CFR 820).
• Support EU MDR transition activities, including gap assessments and documentation alignment.
• Manage manufacturing supply chain activities with CMOs to support PMA modules and readiness for inspections.

Skills

Project management

Regulatory affairs

Cross-functional coordination

FDA PMA submissions

Design controls

Education

Bachelor's degree in Biomedical, Mechanical or Electrical Engineering

Job description

IntelliPro seeks an experienced Project Manager (Consultant) to oversee PMA submissions for a Class III implantable device. Lead end-to-end design control, verification and validation, and manufacturing readiness across diverse teams.

Collaborate with Regulatory Affairs, Quality, Manufacturing, and external partners to align with FDA expectations, risk management, and project timelines. This contract role requires extensive program leadership in late-stage submissions and MDR considerations.