Natasha Nimalasiri
About Natasha Nimalasiri
Natasha Nimalasiri is a Quality and Regulatory Affairs Manager with extensive experience in regulatory vigilance, post-market surveillance, and medical device registration across multiple jurisdictions.
Current Role at TALi
Natasha Nimalasiri serves as the Quality and Regulatory Affairs Manager at TALi. In this role, she is responsible for overseeing quality and regulatory processes within the organization. She has established regulatory vigilance and post-market surveillance processes, ensuring compliance with industry standards. Natasha's work focuses on managing quality and regulatory affairs for digital therapeutics aimed at improving childhood cognitive attention.
Education and Expertise
Natasha Nimalasiri has a strong educational background in biomedical sciences. She earned a Bachelor of Science (Hons) in Biomedical Sciences from the University of Southampton from 2014 to 2017. She furthered her education by obtaining a Master of Biotechnology from the University of Melbourne between 2017 and 2019. Additionally, she completed training at the BSI Training Academy, focusing on the Implementation of the Medical Device Regulation (MDR) for CE Marking in 2020.
Professional Background
Natasha Nimalasiri has held various positions in quality assurance and regulatory affairs. Prior to her current role at TALi, she worked as a Quality Assurance Manager at Tetratherix from 2019 to 2021. She also served as a Quality Assurance and Regulatory Affairs Associate at Plexus RA Pty Ltd for one year. Earlier in her career, she gained experience through internships at National University Hospital and Genetech-Sri Lanka, as well as a project assistant role at UNICEF Sri Lanka.
Regulatory Affairs Management
In her capacity as a Quality and Regulatory Affairs Manager, Natasha is responsible for medical device registration across multiple jurisdictions, including the US, EU, and Australia. She has generated competitor analyses and developed regulatory strategies for pipeline products. Natasha has implemented a compliant Quality Management System for Software as Medical Devices, adhering to relevant ISO standards, and has created essential documentation such as product design dossiers and technical files.
Achievements in Quality Management
Natasha Nimalasiri has successfully established processes for regulatory vigilance and post-market surveillance in her current and previous roles. She has created product design dossiers, technical files, design history files, and device master records, which are critical for compliance in the medical device industry. Her expertise in quality management systems has contributed to the adherence to ISO standards, ensuring that products meet regulatory requirements.