Tosan Eweka serves as a Principal Regulatory Affairs Specialist at Inari Medical, where he leverages his extensive expertise in regulatory compliance and quality assurance within the medical device industry. With a robust background in Technical Documentation and a proven track record in navigating complex regulatory...
Tosan Eweka serves as a Principal Regulatory Affairs Specialist at Inari Medical, where he leverages his extensive expertise in regulatory compliance and quality assurance within the medical device industry. With a robust background in Technical Documentation and a proven track record in navigating complex regulatory landscapes, Tosan plays a pivotal role in guiding the development and approval of innovative medical devices. His responsibilities encompass a wide range of regulatory submissions, including 510(k)s and Pre-Submissions, where he meticulously reviews clinical data and conducts comprehensive literature reviews to ensure that all submissions meet stringent FDA requirements.
In his current role, Tosan is instrumental in developing regulatory submission strategies for both new product developments and sustaining regulatory affairs projects. His keen eye for detail allows him to effectively review Change Orders and assess advertising and marketing promotional materials for compliance with regulatory standards. Tosan's expertise extends to FDA interactions, where he adeptly communicates with regulatory bodies to facilitate smooth approval processes.
A champion of quality system compliance, Tosan is well-versed in ISO 13485, FDA Good Manufacturing Practices (GMP), and the Medical Device Single Audit Program (MDSAP). His knowledge of international regulations, including EU Medical Device Regulation (EU MDR) and REACH compliance, further enhances his ability to support global market access for medical devices. Tosan’s commitment to excellence in regulatory affairs not only ensures compliance but also fosters innovation, ultimately contributing to improved patient outcomes and advancing the field of medical technology.
