Akhil Voruganti

• Review new and historical product complaints to assess data completeness, accuracy, and regulatory compliance requirements.
• Evaluate complaint records and adverse event information to determine Medical Device Reporting (MDR) reportability under FDA regulations.
• Apply regulatory decision trees, complaint handling procedures, and FDA guidance to identify reportable malfunctions, injuries, and adverse events.
• Support preparation and submission of Medical Device Reports (MDRs) through electronic reporting systems in accordance with FDA requirements.
• Perform detailed review of complaint narratives, investigation findings, and supporting documentation to ensure reportability decisions are adequately documented.
• Collaborate with Quality Assurance, Regulatory Affairs, R&D, Manufacturing, and Operations teams to obtain missing information and resolve documentation gaps.
• Conduct retrospective complaint reviews and remediation activities to support regulatory compliance initiatives and reporting obligations.
• Assign and verify adverse event classifications, product problem codes, and regulatory reporting information.
• Support verification activities to ensure complaint investigations are complete, accurate, and compliant with established procedures.
• Maintain complaint files, adverse event records, and regulatory documentation in accordance with HIPAA requirements and internal quality standards.
• Participate in CAPA investigations and quality system activities related to complaint handling and post-market surveillance.
• Support internal audits, regulatory inspections, and compliance assessments involving complaint management and MDR reporting processes.
• Utilize electronic quality systems and documentation platforms to maintain accurate complaint records and regulatory submissions.
• Partner with global quality and regulatory teams to ensure timely reporting and closure of complaint investigations.
• Ensure compliance with FDA 21 CFR Part 803, 21 CFR Part 820, quality system regulations, and company procedures.

• Reviewed product quality complaints, manufacturing investigations, and adverse event records to support regulatory compliance activities.
• Assessed complaint documentation for completeness, accuracy, and reportability in accordance with internal procedures and FDA requirements.
• Conducted complaint investigations to identify product issues, determine root causes, and support risk assessments.
• Collaborated with Quality Assurance, Regulatory Affairs, Manufacturing Sciences, and Operations teams to collect and verify investigation data.
• Supported complaint remediation projects involving historical complaint record reviews and documentation corrections.
• Evaluated manufacturing events and product performance data to identify potential reportable quality issues.
• Assisted with adverse event assessments and escalation activities involving product malfunctions and customer complaints.
• Prepared investigation summaries, quality reports, and supporting documentation for regulatory review.
• Participated in CAPA implementation, effectiveness verification, and complaint trend analysis activities.
• Maintained complaint handling records, investigation files, and quality system documentation within regulated electronic systems.
• Supported audit readiness activities and regulatory inspections related to complaint management processes.
• Ensured compliance with cGMP requirements, FDA regulations, quality system procedures, and data integrity standards.
• Worked closely with cross-functional teams to ensure timely closure of complaint investigations and quality events.
• Assisted in post-market surveillance activities by reviewing product performance data and complaint trends.
• Contributed to continuous improvement initiatives focused on complaint handling, adverse event management, and regulatory compliance.