Pay: $124.61-138.46/hour. W2 Only.
Duration:7 months (through end of 2026) with extensions based on client need and performance.
Location: Local to Boston able to work onsite as needed highly preferred. Open to exceptionally well qualified remote candidates.
Industry: Medical Devices – Class III Long-Term Implantable Devices / Drug Delivery
About the Role
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
- 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.
Qualifications Required
- Bachelor's degree in Biomedical, Mechanical, Electrical Engineering, or a related technical discipline is required.
- 7–12+ years of experience managing complex medical device programs, preferably Class III implantable devices is required.
- Strong working knowledge of FDA PMA submissions, Design Controls, and regulated manufacturing environments is required.
- Demonstrated experience coordinating cross-functional and external teams in late-stage, submission-focused programs is needed.
Preferred Skills:
- 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.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy
Duration:7 months (through end of 2026) with extensions based on client need and performance.
Location: Local to Boston able to work onsite as needed highly preferred. Open to exceptionally well qualified remote candidates.
Industry: Medical Devices – Class III Long-Term Implantable Devices / Drug Delivery
About the Role
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
- 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.
Qualifications Required
- Bachelor's degree in Biomedical, Mechanical, Electrical Engineering, or a related technical discipline is required.
- 7–12+ years of experience managing complex medical device programs, preferably Class III implantable devices is required.
- Strong working knowledge of FDA PMA submissions, Design Controls, and regulated manufacturing environments is required.
- Demonstrated experience coordinating cross-functional and external teams in late-stage, submission-focused programs is needed.
Preferred Skills:
- 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.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy