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.
location: Cambridge, Massachusetts
job type: Contract
salary: $120 - 135 per hour
work hours: 9 to 5
education: Bachelors
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, 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.
qualifications:
Required
- Bachelor's degree in Biomedical, Mechanical, Electrical Engineering, or a related technical discipline. Advanced degree preferred.
- 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.
- Project planning and execution
- Budget and cost control
- Schedule and scope management
- Stakeholder and vendor management
- Strong analytical, organizational, and communication 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.
skills: Regulatory Affairs Operations, Medical Device, Pharmaceuticals and Medical Devices Agency (PMDA), FDA Submissions, Medical Device Regulation (MDR)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
