Principal Project Manager - 29661_P

Job Title: 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

About BEPC:
BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

Apply Now!
If you have strong experience in medical device project management and quality systems, we encourage you to apply. Please submit an up-to-date resume highlighting your device/combo product experience, project leadership, and regulatory expertise.

USOPS

Pay: $98.00 - $104.99 per hour

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• Pharmaceutical or Medical Device industry: 10 years (Required)
• medical devices or combination products: 5 years (Required)
• drug/device development and commercialization: 5 years (Required)
• knowledge FDA (21 CFR 210, 211, 820), EU MDR, and ISO 13485: 5 years (Required)
• project management methodologies and tools: 5 years (Required)
• QMS, audits, and regulatory compliance: 5 years (Preferred)

Location:

• South San Francisco, CA 94080 (Required)

Ability to Commute:

• South San Francisco, CA 94080 (Required)

Ability to Relocate:

• South San Francisco, CA 94080: Relocate before starting work (Required)

Work Location: In person

Salary : $98 - $105