Anjali Nair Email & Phone Number

Bengaluru, Ka, In

Bengaluru, Karnataka, India

Key achievements:*MDSAP*FDA 510 (k)*Biocompatibility assesment, Labelling and cybersecurity.*CDSCO License*Multiple Internal and external audits with minimal non conformances

Bengaluru, Karnataka, India

Vadodara, Gujarat, India

Interfaced with Medical Device manufacturers and Start-Ups in understanding their regulatory needs and bridging the gap with proper regulatory and clinical pathway.Experience in-CDSCO registration & Licensing IVD -ISO 13485 establishment -Gained knowledge on Clinical Research|ICH GCP guidelines -FDA Pre Market Notification - Predicate Analysis and Documentation

Navi Mumbai, Maharashtra, India

Key Responsibilities: To ensure smooth execution of Specimen Collection TrainingTrain new joinees on Relevant Protocols Worked on Learning Management SystemMaintain a batch of employees, Score and track their Skills and development.To mentor for various Network, Company level, Product knowledge and Compliance trainings To develop, improvise and update the Training content and material.Ensure SOPs are followed for every New Product launchGuide Technicians across Network and train them as per NABL normsLeading - Product Launch trainings.

Navi Mumbai, Maharashtra, India

•Food Biotechnology•Qualitative Analysis•Scientific writing•Soxlet extraction

Vashi

Blood & urine Analysis|| HIV tests ||Reporting|| Microscopy||

Master Of Science, Biotechnology

Postgraduate Diploma, Regulatory Affairs

Bachelor Of Science - Bs, Biotechnology