Sheetal Patil
Medical Devices, Labeling, User Manuals, Insert Cards, Perforce, MDR, MDD, CER, CEP, SSCP, Medical Writing, SOA, People Management, Cost, ICSR Case Processing, Adobe Frame maker, MadCap Flare, Copy editing, Tech edit.
- Role
- Senior Manager at HCLTech
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sheetal Patil
14 years experience (8 yrs of Clinical Evaluation Report (CER),Clinical Evaluation Plan…
Experience
Senior Manager
Mar 2021 — Present · Bengaluru, IN
Manage a team of CER writers. POC for customers to understand the scope of the projects, timelines, clarification of queries and updating the customers about the status of the projects, cost estimation, timelines, billing. Writing and reviewing end to end Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), SSCPs according to MDR/MDD Guidelines, utilizing Technical files, IFUs, PMS [Post Marketing Surveillance] documents, RMR (Risk Management Reports) documents, PMCF, Non-clinical documents, Literature articles, assessing equivalence etc.To work on MDD, MDR. And MDD/MDR combo CERs.To work on orthopedic device CERs/CEPs (Hip, Knee, Shoulder, Spine Implants, and instruments).To work on Class I, IIA, IIB and device CERsAttending regular client calls to discuss about CER projects related to timelines, requesting for deficient documents. Responding to all client mails on time for better understanding of deliveries.Actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER process.To mentor/guide newly hired candidates to better their understanding of deliverables.To manage internal team and takes care their career path via goal setting, appraisal.To maintain deliverables and quality metrics data of the teamTo conduct regular team huddles to understand team concerns, provide solutions.To conduct weekly and monthly calls with senior management to provide project details of deliverables, quality scores.To attend internal audits.To collate and provide productivity hours, leave details of team to project management team for billing.
Education
Rajiv Gandhi University of Health Sciences
BDS
2003 — 2010
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