Mathan S
Sr. Quality Specialist- PMS |PSUR| Risk Assessment|QARA| EU MDR 2017/745|
- Role
- Sr Quality Specialist at Medtronic
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Mathan S
Quality Assurance and Regulatory Professional with 11 years of experience in the Medical…
Experience
Sr Quality Specialist
Apr 2024 — Present · Hyderabad, IN
Authored Periodic Safety Update Report (PSUR), PMSR reports in compliance with EU MDR 2017/745.• Conducted Post-Production Risk Assessments, identifying potential safety signals and trends.• Performed statistical analysis on post-market surveillance data (P-value calculation).• Collaborated with cross functional teams (Clinical, Risk Management, Medical Safety, Regulatory) to gather information and ensure regulatory compliance.• Prepared detailed Canada Summary Reports per Canadian Medical Device Regulations.
Education
Sri Eshwar College of Engineering
Bachelor of Engineering (BE), Mechanical Engineering
2009 — 2013
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