Mayur Patel

Background

About Mayur Patel

Life Science leader with over 22 years of experience driving innovation, product development, quality, and regulatory excellence. Currently leading Quality & Regulatory at PA, I champion initiatives that ensure safety, compliance, and commercial success across the pharmaceutical, and MedTech landscape—delivering efficiency, scalability, and value. Product Development • Lead multidisciplinary teams to accelerate complex product development solutions to market. • Orchestrated 25+ successful product launches and rapid-response remediation programs, consistently balancing regulatory rigor, clinical needs, and business outcomes. • Advanced systems engineering practices, integrating design controls across risk management, usability, and robust requirements management for software, hardware, and digital health solutions. Quality Transformation • Lead implementation and transformation of Quality Management Systems (QMS) for global Pharma and MedTech (including GxP, ISO 13485, FDA QMSR, and EU MDR), fostering continuous improvement and compliance while maintaining commercial focus. Collaboration • Collaborate with clinicians, KOLs, and commercial teams to identify unmet needs, develop winning product strategies, and accelerate time-to-market for breakthrough therapies and technologies. • Lecturer for King’s College MSc students on Life Science Regulatory and Product Development topics. EXPERTISE: • GxP (GMP, GLP, GCP) compliance • Quality management (ISO 13485, 21 CFR 820/Part 4) • Medical device & drug delivery device development including Digital health/ SaMD • Medical device regulations: MDR (EU) 2017/745, FDA, MHRA • Patient safety & risk management (ISO 14971) • Global regulatory submissions & lifecycle management • A registered clinical scientist (Health and Care Professions Council UK registered – a regulated professional qualification required to advise safety and effectiveness of products in the NHS), • Published thought leader and passionate about disrupting conventional healthcare system through innovation. SKILLS: • Strategic & operational planning • Cross-functional & multidisciplinary team leadership • Product, program & systems engineering management • Management & Technology Innovation consulting • Stakeholder engagement (internal & external)