Job Details

Senior Quality & Regulatory Consultant (Audit Readiness)

Location: On-site (As required for Audit Support) Walnut Creek CA region
Position Type: Project-Based/Short-Term contract
Pay range: $80.00-$125.00/hour (based on experience)
Start Date: Immediate until project completion

Role Overview
Our high-profile medical research company is seeking a high-caliber Quality professional to join the team for a critical, short-term engagement. The primary objective is to ensure total inspection readiness for an upcoming European Notified Body audit.
We need a "heavyweight" in the Quality space-someone who can jump into the deep end, identify systemic weak spots, and execute document remediation under tight deadlines. You will bridge the gap between Quality and Manufacturing, ensuring our Technical Documentation and processes meet the rigorous standards of MDR, ISO 13485, and UKCA.

Key Responsibilities

• Audit Leadership: Lead the final "sprint" for audit preparation; facilitate and lead interactions with Notified Bodies (specifically targeting success with SGS).
• Technical Document Review: Conduct rigorous reviews of Technical Files to ensure compliance with EU MDR and UKCA requirements. Strong Manufacturing knowledge is required.
• Quality Execution: High-volume processing and refinement of quality documents, including CAPAs, Non-Conformances (NC), and Document Change Orders (DCO).
• Manufacturing Alignment: Evaluate manufacturing compliance against GMP and Notified Body expectations; ensure the "shop floor" matches the "paper trail."
• Gap Analysis: Quickly identify and remediate vulnerabilities in the Quality Management System (QMS).

Qualifications & Requirements

• Education: Bachelor's degree required; MBA, MS, or equivalent advanced degree preferred.
• Experience: 10+ years of leadership experience in Medical Device Quality/Regulatory affairs.
• Regulatory Mastery: Deep expertise in ISO 13485, MDSAP, and EU MDR. A proven track record of leading successful European audits is helpful.
• Technical Proficiency: Strong command of GMP, QSR, and Risk Management frameworks (ISO 14971).
• Communication: Exceptional ability to translate complex regulatory requirements into actionable steps for the manufacturing and quality teams.

Join Us.
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Compensation / Pay Rate (Up to): $80.00 - $125.00