Headline

Medical Device Regulatory Affairs & Complaint Handling Professional | Lead Engineer | PMS | FDA 21 CFR 803/820 | EU MDR | ISO 13485 | CAPA | Risk Management

About

Medical Device Quality Professional with 5+ years of experience in Complaint Handling, Post-Market Surveillance, Regulatory Support, and Quality Systems. Experienced in investigating product complaints, supporting compliance activities, working with SAP, and collaborating with global stakeholders to ensure product quality and patient safety. Passionate about continuous improvement, problem-solving, and contributing to healthcare organizations that prioritize quality, innovation, and customer satisfaction. Open to opportunities in Medical Devices, Quality Assurance, Complaint Handling, and Regulatory Affairs.

Location

Chennai

Work experience

Lead Engineer at HCLTech, Oct 2024 - Present · 1 yr 10 mos, Chennai, Tamil Nadu, India

Senior Engineer at Tata Elxsi, Jun 2022 - Aug 2024 · 2 yrs 3 mos, Pune City, Maharashtra, India

Regulatory Affairs Engineer at Tata Elxsi, Jun 2022 - Jun 2024 · 2 yrs 1 mo, Pune District, Maharashtra, India

R&D Graduate Engineer Trainee (Testing & Regulatory) at Phoenix Medical Systems Pvt. Ltd., Sep 2021 - May 2022 · 9 mos, Chennai, Tamil Nadu, India

Tele coordinator at Aarthi Scans & Labs, Dec 2020 - May 2021 · 6 mos, Bengaluru, Karnataka, India

Education

Bachelor of Engineering - BE, Biomedical Engineering, Mahendra College of Engineerinng