Akash Desai
Medical Device | IVD | Regulatory Affairs | Product Life Cycle Management | Quality Assurance | Lean Six Sigma | RAPS Member
- Role
- Assistant Manager - Regulatory Affairs at Neuroequilibrium Diagnostic Systems Pvt Ltd
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Akash Desai
Navigating the complex regulatory landscape in the medical device sector to bring…
Experience
Assistant Manager - Regulatory Affairs
Neuroequilibrium Diagnostic Systems Pvt Ltd
Feb 2025 — Present · Jaipur, IN
PRRC, Handling end-to-end Medical Device approvals for US-FDA (510k submissions), Europe (CE Marking), Australia (TGA), Japan (PMDA), Indonesia, KSA (SFDA), India (CDSCO), etc. Handling CDSCO (SUGAM and NSWS) portal for Licence Applications Artwork compliance as per EUDAMED requirements (GS1 Labelling) Setting up QMS system and implementation of new standards Handling Notified Body audits for EN ISO 13485:2016, EU MDR, CDSCO, etc. Engaged in Customs and Import/Export regulations Leading QA and QC team for internal quality compliance, Strategic planning and new product launch
Education
KPMG Global Services (KGS)
Certified Lean Six Sigma Green Belt (CLSSGB), Lean Six Sigma Green Belt
2024 — 2024
Dr. D. Y. Patil Vidyapeeth
Master of Science (MSc), Biotechnology
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