QA & Regulatory Affairs Lead

Mesa Laboratories, Inc.; San Diego (CA); On-site; USD 119,000 - 149,000; Full time

Benefits offered by this job

Annual bonus (15%)

Equity award $14,000

401(k) with Safe Harbor match

Job summary

Mesa Labs is seeking a Manager of Quality Assurance & Regulatory Affairs to lead day-to-day QA and regulatory activities, ensuring product quality and compliance across the life cycle. You will coordinate with Engineering, Operations, and R&D to resolve issues and drive continuous improvement.

You will manage a team of QA/Regulatory professionals, translate priorities into actionable plans, and foster a culture of quality and compliance within the organization.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs or equivalent.
• Typically 6–8 years of progressive experience in Quality Assurance and/or Regulatory Affairs in a regulated environment.
• Typically 2–3 years of people leadership or team lead experience.
• Experience working with cross-functional teams and managing multiple quality or regulatory priorities.

Responsibilities

• Manage and lead Quality Assurance activities to support product quality and regulatory compliance.
• Coordinate regulatory submissions, changes, registrations, and communications with authorities.
• Lead, coach, and develop QA/Regulatory staff and allocate resources.
• Maintain audit readiness and support internal and external audits and inspections.
• Drive CAPA investigations and monitor effectiveness; resolve quality issues across functions.
• Partner with Engineering, Operations, Supply Chain, R&D, and Commercial to ensure quality throughout the product lifecycle.
• Promote continuous improvement and standardized processes across the team.

Skills

Quality Assurance

Regulatory Affairs

Leadership

CAPA

Audits

Risk Management

Cross-functional Collaboration

Project Management

Communication

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs

Job description

Mesa Labs is seeking a Manager of Quality Assurance & Regulatory Affairs to lead day-to-day QA and regulatory activities, ensuring product quality and compliance across the life cycle. You will coordinate with Engineering, Operations, and R&D to resolve issues and drive continuous improvement.

You will manage a team of QA/Regulatory professionals, translate priorities into actionable plans, and foster a culture of quality and compliance within the organization.