Silmoon Hathiyari
Project Manager I EU MDR I CER I PMCF I PMS I ISO 13485 I Risk Analysis I Usability Engineering I Biocompatibility I Sterilization I Stability Studies
- Role
- Specialist at Tata Elxsi
- Location
- Valsad, GJ, IN
- LinkedIn followers
- 500 followers
About Silmoon Hathiyari
With almost 8 years of varied experience strived to be an effective communicator, team member and project lead with skills in troubleshooting, abilities in planning, and managing resources with the goal of accomplishing tasks. In my career journey, I have been fortunate and privileged to have come across some wonderful people as my managers and seniors, business owners, colleagues, and mentors who have helped me acquiring phenomenal learning and facing challenging opportunities from the very beginning of my career; in a way made me high impact contributor in multiple domains. In my current role involves in strategizing, developing, reviewing CER, CEP, SSCP and PMCF accomplishing entire project.During my tenure with Medline, I have been part of the APAC region working for various country-specific registrations there in supporting business needs.As a consultant in Alceon, core work included drafting of Clinical Evaluation Report as per MEDDEV Rev 04 for devices like PTCA /PTA catheter, gelatin sponge, CVC catheter, blood collecting bag, IV catheter, and spinal needle.As regulatory affairs professionals in Meril have played a key role in the planning and preparation of Design History files and Technical files viz. PTCA Catheters, PTA Catheters, Bare Metal Coronary Stents, Drug-Eluting Stents, self-expanding Stents, Vascular Closer Device, Aspiration Catheter, Sinuplasty System, Heart valves, etc. specifically for CE marking of devices.
Experience
Specialist
Aug 2021 — Present · Pune, IN
Education
Veeraytan Inst of Pharmacy,G.T.U.
B.pharm, Pharmacy
2009 — 2013
St.joseph Convent
H.S.C, Science
2007 — 2009
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