Sruthi Thopalle
Prrc and Regulatory Compliance Lead @Sinclair
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WORK HISTORY
Prrc and Regulatory Compliance Lead @Sinclair
DE
EDUCATION
KLE University
Master's degree
RGUHS University
Bachelor of Pharmacy - BPharm
Sri Chaitanya College of Education
Master of Science - MS
SKILLS
ABOUT SRUTHI THOPALLE
9 Years of Healthcare, includes 7 years of Quality Management experience and 2 years of Post Market experience. I love solving complex RA Puzzles and making sure products get to patient safety• Supported CE mark for a class IIb medical device in 5months.• Led QMS audit with a minor Non-conformity. Skilled in: • eQMS, CAPA, ISO 13485, ISO 14971, IEC 60601, IEC 62304 (SaMD)• Medical Device Regulations (MDR): electronic/digital labeling (e-IFU) • Risk Management• NC/CAPA/Quality Systems, Audits, Inspections• Complaint Management• Supplier Quality Management• Cross-functional Projects, Quality Reviews, KPIs• Team / People Manager, Entrepreneur
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