PMS Analyst
A detail-oriented life science professional specializing in post-market surveillance (PMS) for medical devices. Possesses direct experience in the complete complaint handling lifecycle, from intake and documentation in Salesforce to conducting FDA reportability assessments and executing thorough investigations. Skilled in preparing detailed Complaint Investigation Reports (CIR), writing adverse ev...
Experience: 0.9+ years
KISHORE P provides regulatory consulting services to clients in:
Holds a Bachelor of Science in Nursing from SRM College of Nursing, SRMIST, providing a strong clinical and life sciences foundation. This educational background offers a practical, patient-centric perspective on medical device safety and performance. The combination of clinical training and a formal degree equips this professional with a deep understanding of medical terminology and healthcare settings, which is invaluable for accurately assessing adverse events and supporting post-market surveillance activities for medtech companies.
This professional has gained specialized experience as a Post-Market Surveillance (PMS) Analyst at a major global technology company, focusing on medical devices. Their background includes managing the complete complaint handling lifecycle, from intake and documentation to investigation and closure. They have demonstrated expertise in conducting FDA reportability assessments, preparing detailed Complaint Investigation Reports (CIR), and submitting adverse event reports. This experience, complemented by a background as a Staff Nurse in a hospital setting, provides a unique blend of hands-on regulatory process knowledge and real-world clinical insight, making them highly effective in ensuring product safety and compliance.
A detail-oriented life science professional specializing in post-market surveillance (PMS) for medical devices. Possesses direct experience in the complete complaint handling lifecycle, from intake and documentation in Salesforce to conducting FDA reportability assessments and executing thorough inv...
With nearly a year of focused experience at a major global medtech company, this consultant offers highly relevant and current expertise in post-market surveillance. They possess direct, hands-on skills in the complete complaint handling lifecycle for Class II and Class III devices, including FDA reportability assessments, CIR preparation, and submissions compliant with 21 CFR 820.198. Their technical proficiency is enhanced by a background in cardiovascular and general surgery devices. What truly elevates their value is their foundational education as a Bachelor of Science in Nursing, providing a critical clinical perspective to regulatory analysis that ensures a deep understanding of patient safety and adverse events.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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