Poshitha Sai

Regulatory Post-Market Surveillance & Vigilance Specialist with 4+ years of medical device complaint handling experience (8+ years total professional experience), specializing in global regulatory reporting (eMDR, EU MDR, FDA 21 CFR Part 820/803/806) and ISO 13485-compliant QMS. Skilled in preliminary complaint classification, IMDRF risk coding (Hazard, Harm, Severity), product analysis review, MDSAP-aligned documentation, and cross-functional collaboration. Proven track record in process improvement, audit readiness, and high-accuracy complaint file closure.

Vigilance Specialist - Medtronic Engineering & Innovation Center - Hyderabad, India

(2022-06)

• Perform preliminary complaint classification and escalate high-risk events requiring additional review.
• Conduct follow-up with customers/reporters via calls and email to retrieve additional information, including RMA details.
• Evaluate complaints for global regulatory reporting (eMDR) in alignment with company procedures and international regulations, including EU MDR and FDA 21 CFR Part 803/806.
• Review product analysis investigations and determine event cause/contribution.
• Assign Hazard, Harm, Severity, and IMDRF risk codes accurately.
• Escalate complex complaints to product quality, manufacturing, and design engineering teams.
• Evaluate documentation for completeness and initiate additional actions required for complaint closure.
• Approve complaint files for closure once all required actions are completed.
• Support new hire training and ongoing regulatory compliance training.
• Collaborate with SMEs on escalated investigations and regulatory response activities.
• Contributed to a 15% reduction in audit findings through ISO 13485 and MDSAP-aligned audit support.
• Improved complaint closure efficiency by 20% through process enhancements.

Senior Technical Support Associate - Tech Mahindra - Hyderabad, India

(2018-09 - 2022-06)

• Conducted technical investigations and corrective actions, maintaining 98% first-time resolution.
• Authored documentation and incident reports aligned with internal quality standards.
• Mentored associates, improving team quality metrics by 12%.

Customer Service Executive - HSBC - Visakhapatnam, India

(2017-01 - 2018-09)

• Executed high-volume operations with 100% compliance to data security and quality requirements.
• Improved service accuracy and customer satisfaction by partnering with QA teams.

Bachelor of Technology (B.Tech) - Computer Science Engineering - MVGR College of Engineering (2016)