Shubham Kumar
Senior Associate @ Freyr Solutions | Regulatory Affairs, Quality Assurance
- Role
- Senior Associate at Freyr Solutions
- Location
- Jalandhar, IN
- LinkedIn followers
- 500 followers
About Shubham Kumar
As a Senior Associate at Freyr Solutions, I lead and support various regulatory affairs projects for medical device manufacturers in different markets, such as the US, EU, India, and Australia. I have a strong track record of obtaining regulatory approvals and certifications for multiple clients, such as CDSCO import licenses, CE Marking certificates, ARTG listings, and FDA clearances. I ensure compliance with the relevant standards and regulations, such as ISO 13485:2016, EU MDR 2017/745, and USFDA 21 CFR 820, by writing and reviewing quality and regulatory documents, such as DMFs, PMFs, SOPs, and technical files.(50 tokens) I have a Bachelor\'s degree in Biomedical Engineering from Lovely Professional University, where I also developed a strong interest and skill in machine learning. I apply this domain expertise to enhance the detection and diagnosis of Alzheimer\'s disease, a prevalent and incurable neurodegenerative disease. I have published a review article on this topic in the Journal of Interdisciplinary Cycle Research, and I have completed Google\'s Data Analyst Certificate. I am passionate about using data and technology to improve healthcare outcomes and quality. I am open to travel, relocate, and learn new skills and domains.
Experience
Senior Associate
Apr 2023 — Present · Hyderabad, IN
Education
C.J.S Public School
Senior Secondary , General Studies
2004 — 2016
Lovely Professional University
Bachelor's, Science and Technology [Biomedical Engineering]
2017 — 2021
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