Suthir Akash P

Regulatory Engineer - Medical Device

About me

Regulatory Engineer – Medical Device | DHF | ISO13485 | ISO14971 | Remediation | TrackWise | Change Control | MQMS | Medical Device Regulatory| 510k | GSPRC | Medical Quality | CAPA | MDR | CER

Work Experience

Senior Regulatory Associate
Genpact 2025-01-01 - Present Medical Device – Labeling and DHF Remediation: I have started working on a new scope, progressing from the training phase to execution. I possess robust knowledge of medical device regulatory requirements.
Regulatory Associate
HCLTech 2022-11-01 - 2025-01-01 I had been working on Medical Device DHF Remediation and Change Control Process for Medical Device Marketed in EU, US and other countries . MDD to MDR remediation under New Regulations and Standards for comply with Design Requirements.

Education

Bachelor of Engineering - BE, Biomedical/Medical Engineering
Professional - Sri Shakthi Institute of Engineering and Technology 2018 – 2022

Painpoints

Pls tick the issues faced in the previous interviews.

Not applicable

Open-To-Work

Are You Open To Work?

Definitely yes
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