Medical Device Principal Project Manager

Principal Project Manager Location:South San Francisco, CA 94080 (100% Onsite) Employment Type:W2 Contract, 8 Month contract with possibility for extensions Pay Rate:$98.00 – $104.99/hour (based on experience) Work Schedule:Monday – Friday, standard business hours (must support global hours as needed) Role Overview: BEPC is seeking aPrincipal Project Managerto support our client’s medical device and combination product programs. This is a high-impact role combiningproject management leadershipwithQuality Management System (QMS) support , ensuring the successful execution of complex development programs while maintaining compliance with regulatory standards. The ideal candidate brings deep experience inmedical devices or combination products , strong project execution skills, and a solid understanding of regulatory and quality systems. Key Responsibilities: Project Management & Execution Leadend-to-end project managementacross device development lifecycle (design through post-approval) Translate strategy into actionabledevelopment and execution plans Drivecross-functional collaborationand milestone delivery Manageproject timelines, risks, budgets, and resources Guide teams throughstage-gate processes and governance reviews Compliance & QMS Support Support implementation and continuous improvement of theQuality Management System (QMS) Manage and maintainDesign History Files (DHF)and documentation Ensureaudit and inspection readiness , including preparation and remediation activities Align project execution withregulatory requirements and quality standards Operations & Continuous Improvement Identify and mitigateproject and compliance risks Leadprocess improvement initiativesand optimize project management tools Supportresource planning and cost tracking Collaborate across global teams and stakeholders Qualifications: Bachelor’s degreein Engineering, Science, or related field 12+ years of experiencein the Pharmaceutical or Medical Device industry 5–6+ years in medical devices or combination products Strong experience indrug/device development and commercialization Deep knowledge ofFDA (21 CFR 210, 211, 820), EU MDR, and ISO 13485 Proven expertise inproject management methodologies and tools Strong leadership, communication, and stakeholder management skills Preferred Qualifications: PMP certificationor equivalent project management credential Experience managingglobal, cross-functional programs Strong background inQMS, audits, and regulatory compliance Contract Details: Global Collaboration:Availability for meetings across time zones (early Pacific hours as needed) Travel:Occasional (1–2 times per year) Employment Type:W2 Contract, 8 Month contract with possibility for extensions Pay Rate:$98.00 – $104.99 per hour