Medical Device Principal Project Manager (South San Francisco)

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 a Principal Project Manager to support our client’s medical device and combination product programs. This is a high-impact role combining project management leadership with Quality Management System (QMS) support , ensuring the successful execution of complex development programs while maintaining compliance with regulatory standards.

The ideal candidate brings deep experience in medical devices or combination products , strong project execution skills, and a solid understanding of regulatory and quality systems.

Key Responsibilities:

Project Management & Execution

• Lead end-to-end project management across device development lifecycle (design through post-approval)
• Translate strategy into actionable development and execution plans
• Drive cross-functional collaboration and milestone delivery
• Manage project timelines, risks, budgets, and resources
• Guide teams through stage-gate processes and governance reviews

Compliance & QMS Support

• Support implementation and continuous improvement of the Quality Management System (QMS)
• Manage and maintain Design History Files (DHF) and documentation
• Ensure audit and inspection readiness , including preparation and remediation activities
• Align project execution with regulatory requirements and quality standards

Operations & Continuous Improvement

• Identify and mitigate project and compliance risks
• Lead process improvement initiatives and optimize project management tools
• Support resource planning and cost tracking
• Collaborate across global teams and stakeholders

Qualifications:

• Bachelor’s degree in Engineering, Science, or related field
• 12+ years of experience in the Pharmaceutical or Medical Device industry
• 5–6+ years in medical devices or combination products
• Strong experience in drug/device development and commercialization
• Deep knowledge of FDA (21 CFR 210, 211, 820), EU MDR, and ISO 13485
• Proven expertise in project management methodologies and tools
• Strong leadership, communication, and stakeholder management skills

Preferred Qualifications:

• PMP certification or equivalent project management credential
• Experience managing global, cross-functional programs
• Strong background in QMS, 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