What are the responsibilities and job description for the Medical Device Principal Project Manager position at BEPC Inc. - Business Excellence Professional Consulting?
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
Salary : $98 - $105