Clinisys is a global provider of intelligent diagnostic informatics solutions and expertise designed to redefine the modern laboratory, across healthcare, life sciences, and public health. Millions of diagnostic results and data insights are generated every day using Clinisys’ platform and cloud-based solutions in over 4,000 laboratories across 39 countries. Our 1,450+ expert professionals, headquartered in Woking, UK and Tucson, Arizona, have a shared mission to enhance the effectiveness of diagnostic workflows in any laboratory or testing environment and keep citizens and communities healthier and safer.

Role Description

The Manager, Quality and Regulatory Systems is responsible for the development, implementation, and continuous improvement of quality and regulatory systems to ensure compliance with applicable standards and regulations (e.g., ISO 13485, 21 CFR 820, EU MDR/IVDR, etc.). This role leads cross-functional initiatives, oversees audits and inspections, manages key quality system elements, and ensures alignment between quality and regulatory requirements.

Responsibilities

• Develop, maintain, and improve the Quality Management System (QMS) in accordance with regulatory requirements and industry standards.
• Ensure compliance with applicable regulations (e.g., FDA, ISO, ICH, EU MDR/IVDR and lead internal and external audits.
• Oversee document control, CAPA, change control, training, risk management, and other QMS subsystems.
• Manage regulatory submissions and interactions with health authorities as needed.
• Collaborate with cross-functional teams (R&D, Operations, Regulatory, Support, Services, Marketing, etc.) to support product development and commercialization.
• Monitor changes in regulatory requirements and ensure timely updates to internal procedures and systems.
• Train and mentor quality staff and ensure organizational readiness for inspections.
• Lead continuous improvement initiatives to increase quality, efficiency, and compliance.
• Serve as quality/regulatory representative in project teams and strategy discussions.
  
  

Knowledge, Skills & Abilities

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.
• 5–8+ years of experience in quality assurance and/or regulatory affairs, preferably in [industry – e.g., medical device, pharma, biotech, software, etc.].
• Strong understanding of quality systems regulations (e.g., FDA QSR, ISO 13485, MDR, IVDR).
• Experience with audits, CAPA management, and regulatory submissions.
• Excellent communication, leadership, and organizational skills.
• Detail-oriented, analytical, and proactive mindset.
• Experience with electronic QMS tools such as Greenlight Guru is a plus.