Gobiram Selvaraj
Quality Assurance & Regulatory Affairs | Medical Devices | IRCA Certified Lead Auditor – ISO 13485:2016
- Role
- Medical Devices Regulatory Consultant at L&T Technology Services
- Location
- Mysuru, KA, IN
- LinkedIn followers
- 500 followers
About Gobiram Selvaraj
I bring 9+ years of expertise in Quality Assurance (QA) and Regulatory Affairs (RA)…
Experience
Medical Devices Regulatory Consultant
Mar 2025 — Present · Mysore, IN
Conducted gap assessments to identify compliance risks against updated regulatory standards- Led remediation projects ensuring alignment with FDA, EU MDR, and ISO requirements- Developed CAPA based on audit findings, ensuring sustainable compliance- Revised technical documentation (risk management, clinical evaluation reports)- Supported regulatory strategy and submission planning for product updates and legacy device transitions- Delivered internal training on regulatory updates and best practices.
Education
Birla Institute of Technology and Science, Pilani
MBA, Quality Management
U R C PALANIAMMAL MATRIC HIGHER SECONDARY SCHOOL
Higher secondary school leaving certificate, High School/Secondary Diplomas and Certificates
2007 — 2009
Bannari Amman Institute of Technology
Bachelor of Technology (BTech), Biotechnology
2009 — 2013
Skills
- Hplc
- Microsoft Office
- Chromatography
- Spices
- Gas Chromatography
- Food
- Biotechnology
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