Mohit K.
Regulatory Affairs Manager
- Role
- Regulatory Affairs Manager at Auxein Medical
- Location
- Sonipat, HR, IN
- LinkedIn followers
- 500 followers
About Mohit K.
I am a Regulatory Affairs Manager with extensive experience in the orthopedic industry. My expertise spans ensuring compliance with global regulatory standards, including US FDA, EU MDR, and ISO certifications. I work closely with cross-functional teams to guide products through the regulatory process, ensuring timely submissions and successful approvals. My focus is on ensuring the safety and efficacy of orthopedic devices while keeping up with evolving regulatory requirements and industry trends.
Experience
Regulatory Affairs Manager
Jun 2024 — Present
Education
Academy of Scientific and Innovative Research
Doctor of Philosophy - PhD, Engineering
Punjab Engineering College
Master's in Engineering, Industrial and Product Design
2013 — 2015
Punjab Technical University, Jalandhar
Bachelor's degree, Mechanical Engineering
2008 — 2012
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