Srishti Sinha
Regulatory Affairs Professional | EU MDR | USFDA | Medical Devices
- Role
- Jr Regulatory Affairs Executive at Maven Profcon Services LLP
- Location
- Gandhinagar, IN
- LinkedIn followers
- 500 followers
About Srishti Sinha
I am a Biomedical Engineering graduate, with hands-on experience in regulatory affairs…
Experience
Jr Regulatory Affairs Executive
Sep 2024 — Present · Ahmedabad, IN
My responsibilities including but not limited to- Preparation of technical documentation as per EU MDR 2017/745, covering Annex II & requirements- Conducting clinical evaluation, including literature search, literature appraisal, drafting search protocols and reports, and preparing CEPs & CERs- Performing risk management as per ISO 14971, including risk analysis, FMEA, and drafting risk management policy, plans, and reports- Drafting usability checklists, protocols, and reports in line with device design requirements- Drafting PMCF plans, analysing collected PMCF feedback/survey data, and preparing PMCF reports- Identifying biocompatibility endpoints and drafting BEP & BER in accordance with ISO 10993 - Compiling applicable GSPR checklists for compliance demonstration- Solving CAPAs & NCs raised by Notified Bodies with evidence-based responses- Identifying product classification as per EU MDR (class, rules, sub-rules)- Identifying product codes, regulations, and predicate devices for US FDA submissions under 510(k)
Education
Government Engineering College,Gandhinagar
Biomedical engineering
2020 — 2024
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