Director of QA & Regulatory Affairs

About Us

We are seeking an experienced and highly qualified Director of Quality Assurance and Regulatory Affairs to lead quality systems and ensure compliance with all applicable regulatory requirements. This role will oversee quality assurance processes, regulatory submissions, and audits to maintain product integrity and adherence to industry standards.

ChromoLogic LLC (www.chromologic.com) is a world-class innovation center with advanced scientific research and development in the medical, aerospace and security markets. Covisus Inc. (www.covisus.com) is a VC-funded spin-off from ChromoLogic that has developed an award-winning and industry-leading technology for tagless tracking of assets based on its vTag® technology.

Key Responsibilities

• Own end-to-end project management for medical device development from concept through FDA clearance/approval and U.S. launch
• Build and maintain integrated product plans, timelines, budgets, and resource plans in a startup environment with evolving priorities
• Develop and implement quality assurance strategies and regulatory compliance programs (FDA 510(k), PMA, IDE, drug approval, IND, pre-submission)
• Ensure adherence to FDA, ISO, and other relevant standards (IRBs, HRP, clinical study protocols, animal study protocols (IACUC, OLAW, ACURO))
• Oversee internal and external audits, inspections, and certifications
• Manage regulatory submissions and maintain documentation for compliance
• Collaborate with cross-functional teams to ensure quality throughout the product lifecycle
• Lead and mentor QA, regulatory, and safety teams to achieve organizational goals
• Monitor changes in regulations and update company policies accordingly

Qualifications

• Bachelor's or Master's degree in engineering, life sciences, or related field
• 10+ years of experience in QA and regulatory roles
• 5+ years in leadership roles, with a proven track record of managing people, projects, and processes
• Excellent communication, leadership, and strategic skills

What We Offer

• Competitive salary and benefits package, including stock options
• Opportunities for professional growth and development
• A collaborative and inclusive work culture
• The chance to work on cutting-edge technology projects that make a real-world impact