Nazeer Khan serves as a Principal Regulatory Affairs Specialist at Medtronic, where he plays a pivotal role in ensuring compliance and market approval for a diverse range of medical devices, particularly focusing on Renal Access and both acute and chronic devices. With extensive experience in...
Nazeer Khan serves as a Principal Regulatory Affairs Specialist at Medtronic, where he plays a pivotal role in ensuring compliance and market approval for a diverse range of medical devices, particularly focusing on Renal Access and both acute and chronic devices. With extensive experience in Regulatory Affairs for Class I, II, and III medical devices, Nazeer adeptly navigates the complexities of the evolving regulatory landscape, particularly under the European Union Medical Device Regulation (EUMDR). His expertise encompasses not only regulatory compliance but also post-market clinical activities, which are crucial for maintaining product safety and efficacy in the market.
Nazeer’s current projects involve supporting the implementation of post-market clinical studies, where he collaborates with cross-functional teams to gather and analyze clinical data that informs ongoing product development and regulatory submissions. His proficiency in FDA regulations and guidelines ensures that Medtronic’s devices meet stringent safety and performance standards, facilitating timely market access across various global jurisdictions.
In addition to his regulatory expertise, Nazeer is well-versed in drug research and development, with skills in technology transfer and analytical techniques such as gas chromatography and gel electrophoresis. His background in the pharmaceutical and biotechnology sectors further enriches his approach to regulatory affairs, allowing him to integrate scientific insights with regulatory requirements effectively. Nazeer’s commitment to maintaining industry compliance and his ability to adapt to the dynamic regulatory environment make him an invaluable asset to Medtronic and the broader medical device industry.
