DIRECTOR, QUALITY ASSURANCE & COMPLIANCE
With 15 years of combined medical device, pharmaceutical and biologics/tissue industry experience, Niyati Patel is Experic’s director of quality assurance and compliance. Patel is responsible for leading the company’s quality department and overseeing compliance with FDA, ISO and other regulatory bodies. Deeply knowledgeable about quality management system processes and requirements, Patel is considered an expert at building robust quality systems from the ground up. She has independently and successfully managed numerous regulatory inspections with governing agencies such as the FDA, EMA, ISO, Health Canada, ANVISA, TGA and more, and she has an extensive knowledge of applicable regulations.
Patel has held various quality management and quality engineering leadership positions in multiple companies, including Extremity Medical, Integra LifeSciences, Bracco Diagnostics, Immucor, Biocoat and Eli Lilly. Her hands-on ability in problem-solving and corrective action planning has resulted in a positive organizational shift in culture, mindset and education toward quality. An active member of multiple industry organizations, Patel holds a master’s degree in biomedical engineering from New Jersey Institute of Technology, with a specialization in tissue engineering.