Job Title: Project Manager
Location: Cambridge, Massachusetts (On-site)
Job Summary: We are seeking a driven professional to lead complex medical device development and regulatory submission activities within a high-impact portfolio. Our team empowers critical advancements in long-term implantable device innovation and ensures alignment with the highest industry standards.
Responsibilities:
- Lead integrated project plans to finalize design control deliverables and complete regulatory Premarket Approval (PMA) Modules, ensuring alignment with key submission milestones and timelines.
- Coordinate with Regulatory Affairs and Quality teams to meet all FDA PMA, Design Controls (21 CFR 820), and risk management (ISO 14971) requirements, as well as support EU MDR transition and technical documentation alignment.
- Oversee device design verification and validation (DV) activities, ensuring protocol completeness, traceability, and readiness for regulatory review, including human factors, bench, and clinical testing coordination.
- Manage clinical product manufacturing supply chain activities, facilitate collaboration with Contract Manufacturing Organizations (CMOs), and support readiness for regulatory review, inspections, and risk mitigation.
Required:
- 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.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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