Akash Ghode
Senior Regulatory Engineer | MD QMS | Auditor | ISO 13845 | 21 CFR 820 | EU MDR | US FDA | CDSCO
- Role
- Senior Engineer - Medical Electronics at Tata Elxsi
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Akash Ghode
Experienced Senior Regulatory Engineer with expertise in technical reviews and audits of medical device files (TCFs, DHFs, DDs) in accordance with global regulations, including EU MDR 2017/745, IVDR 2017/746, MDD/93/42/EC, IVDD/98/73/EC, US FDA, TGA, and Health Canada.Proficient in identifying and analyzing gaps in quality manuals, quality system procedures, and regulatory documentation, ensuring compliance with standards such as ISO 13485, ISO 14971, ISO 15223-1, ISO 20417, IEC 62304, IEC 60601-1, ISO 10993-1, IEC 82304, and IEC 62366.Skilled in preparing risk management documentation, conducting CAPA remediation, supplier evaluations, and regulatory submissions, and providing strategic guidance on regulatory pathways.Involved in audits and technical reviews for medical device certification decisions, including Design Verification and Validation audits as per ISO 13485, ISO 9001, and IMDR 2017, with experience in managing client communications for technical query resolution.Quality Representative in design and development projects for Software as a Medical Device (SaMD)
Experience
Senior Engineer - Medical Electronics
Jul 2023 — Present · Pune, IN
Education
Savitribai Phule Pune University
Bachelor of Pharmacy - BPharm
2016 — 2020
National Institute of Pharmaceutical Education and Research - Ahmedabad
MS (pharm)
2020 — 2022
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