Avani Pitale

Background

About Avani Pitale

Experienced Regulatory Affairs Specialist with over 4.5 years of expertise in regulatory compliance, change control management, global submissions, and stakeholder coordination. Proficient in regulatory documentation, risk assessment, and ensuring alignment with international drug and medical device regulations, including ISO 13485 and FDA requirements. Proficient in regulatory software including ETQ, TRU ENOVIA, CEDMS, Veeva Vault and RIMS. I am passionate about learning new skills and enhancing my professional development. I recently completed a certification course on the non-technical skills of effective data scientists, which has broadened my perspective on how data can be used to inform decision-making and drive innovation. I am always eager to take on new challenges and contribute to the success of my organization. Adaptive and dynamic in nature with an established history of accomplishing tasks while transforming our work processes.