Pay Range: $50 - 104/hr depending on experience
Contract: 8 months with possible extension and/or conversion
100% onsite in South San Francisco, CA
Job Description:
- Manage complex projects across the development pipeline—from initial design to post-approval—while managing the regional business and compliance activities for the Device
- Development. Strategic Planning: Translate device strategy into actionable plans, defining "inspection-ready" Design & Development Plans.
- End-to-End Management: Lead a range of projects including development pipelines, line extensions, and technology initiatives.
- Team Performance: Foster high-performing team dynamics, facilitating efficient decision-making, issue resolution, and cross-functional collaboration.
- Governance & Business Gates: Navigate teams through business process stage-gates and support technical advisory or governance committee reviews.
- QMS Implementation: Drive implementation, maintenance, and continuous improvement of the Quality Management System (QMS) including the tracking of metrics
- Records Management: Manage Design History Files (DHF) and document repositories to ensure accuracy, completeness, and regulatory compliance.
- Audit Readiness: Manages audit and inspection readiness, including preparation for internal audits and Health Authority inspections, and oversees timely remediation of findings.
Qualifications:
- Education: B.S. degree in Engineering, Technical Field, or a related discipline.
- Experience: At least 12 years in the Pharmaceutical or Medical Device industry.
- Minimum 5–6 years specifically in medical devices or combination products.
- Proven experience in drug/device development and commercialization.
- Regulatory Expertise: Extensive knowledge of EU MDR, FDA 21 CFR Parts 210, 211, & 820 (including 820.30 design controls), and ISO 13485.
- Project Management: Proficiency in PM best practices and software; PMP certification is considered a significant asset.
