Tech Stack

Description

You will lead global regulatory strategy and quality oversight for adaptive diagnostics, ensuring compliance with FDA and international regulations. You'll manage Regulatory Affairs and Quality Assurance teams, develop regulatory strategies, oversee submissions (e.g., 510(k), CE marks), and drive continuous improvement of the QMS.

Requirements

• BA/BS in life sciences (MS, PhD preferred).
• 20+ years progressive management in global QA and regulatory affairs in diagnostic/medical device/life sciences (MS+18, PhD+12).
• Prior experience leading a function or sub-function.
• Expertise with all phases of product development lifecycle.
• Extensive experience with ISO, CLIA, CAP, CLEP, GxP compliance.
• Hands-on experience in global regulatory filings (510(k), CE marks).
• History of direct interactions and negotiations with regulatory agencies.
• Experience implementing and managing quality/compliance systems and inspection readiness.

Responsibilities

• Develop, lead, and drive the execution of global regulatory strategy and quality oversight.
• Manage RA and QA teams to define appropriate regulatory pathways aligned with corporate objectives.
• Lead development, management, and continual improvement of the Quality Management System (QMS).
• Provide counsel, training, and interpretation of FDA and global regulatory requirements.
• Oversee preparation and filing of regulatory documents with FDA and international agencies.
• Develop and maintain external relationships with opinion leaders and regulatory officials.
• Direct development of systems for ongoing review of product design and manufacturing changes.
• Lead management of deviation events impacting compliance or business risk.
• Facilitate management review of QMS and drive continuous improvement.
• Support quality design and assurance strategy for new product development.