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- Suthir Akash P
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
Skills
Work Experience
Senior Regulatory Associate
Genpact
2025-01-01
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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
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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
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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