Sathya G
Principal Specialist-Regulatory affairs at Vantive Healthcare Technologies Pvt Ltd (QA /RA) MDD/EU MDR & EU IVDR/DHF Remediation/QMS/Risk Management/Internal Auditor/Project Management/ISO 13485/ISO 14971
- Role
- Associate Consultant at Tata Consultancy Services
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sathya G
Principal Specialist – Regulatory Affairs (QA/RA) at Vantive Healthcare Technologies Pvt.…
Experience
Associate Consultant
Jun 2022 — Present · Chennai, IN
Performed Product Gap Assessment and DHF (Technical file preparation) against EU/MDR:2017 & EU/IVDR:2017 standards. Performed SSCP, PEP, PER, PMSR & PSUR reports preparation against EU/MDR & EU/IVDR standards. Performed standard assessment of IEC60601-1, IEC62304 & etc, Risk management (ISO 14971) documents preparation and review with client (Risk Management Plan, Risk Management Report & Risk Benefit Analysis Report, FMEA, Hazards documents & etc,) Device registration country specific documents (EU, China, Russia, Canada & etc.) preparation and submitted to notified body. Worked with Notified Body for document release. Performed MDR and IVDR QMS Remediation Project against EU/MDR & EU/IVDR:2017. Performed ISO 13485 Quality management system implementation for 10 Manufacturing sites Performed draft consolidated documents for 34 QMS element against ISO 13485 and client requirements (Multisite Operating Procedure, Multi site work instruction, Gap assessment report preparation, Quality Manual Redline document, Quality Manual Index preparation & review). Performed Complaint handling and incident analysis (JNJ Manufacturing unit as well Wall greens boots health care stream). Internal team monitoring complaints review, daily audits conducting, compliance ensuring in DSUs,daily shift planning, weekend support activities Performed Shift ROTA, WSR,MSR,all the governance and project management activities with respect to TCS and Client. Performed project Management operation activities as per TCS Process. Performed FMEA Remediation activities for DFMEA, PFMEA & UFMEA preparation & review. Performed P1 & P2 Calculation, Defect diagram,730Report preparation and review. Performed Product Quality Analyst Role, Final inspection performed for stream specific all type of devices. Performed Project Compliance Index Audit documents & IQA Audit documents preparation and Handled regulatory & quality teams effectively.
Education
RAJA'S HIGHER SECONDARY SCHOOL KALLAPERAMBUR
Bachelor of Engineering - BE
2007 — 2011
Raja's higher secondary school
Bachelor of Engineering - BE
2007 — 2011
Kings College of Engineering
Bachelor of Engineering - BE
2007 — 2011
Raja's Higher secondary school
Electrical, Electronics and Communications Engineering
2007 — 2011
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.