Sathish U
Clinical Product Surveillance Leader @ GE HealthCare | MBA in Quality Management
- Role
- Clinical Product Surveillance Leader at GE医疗
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sathish U
My academic foundation, strengthened by an MBA in Quality Management from BITS Pilani…
Experience
Clinical Product Surveillance Leader
Sep 2020 — Present · Bengaluru, IN
A Clinical Leader in Product Surveillance within the field of ultrasound plays a critical role in ensuring the safety and effectiveness of ultrasound devices & responsibilities include:• Complaint Handling and Trending: Utilize clinical product knowledge to handle complaints related to GE Healthcare Ultrasound products. Implement effective methods and procedures for trending and analyzing complaints.• Regulatory Reporting: Support regulatory reporting by ensuring timely and accurate submission of adverse events (AEs) and safety-related information. Collaborate with regulatory teams to establish appropriate corrective and preventive actions (CAPA).• Safety Evaluation: Evaluate safety data, including adverse events, to assess their impact on patient safety. Identify complaints that require further evaluation under regulatory guidelines.• Collaboration with Design Teams: Engage with product design owners to determine effective CAPA strategies. Provide clinical input for product improvements and enhancements.• Global Impact: Contribute to global safety reporting, ensuring compliance with safety regulations.• Maintain a strong focus on patient safety and product quality.• This role is pivotal in maintaining patient trust and ensuring the safe use of ultrasound technology.
Education
Rajiv Gandhi Institute of Technology, BANGALORE
BE, BioMedical Engineering
2008 — 2012
SJR, Rajajinagar
PUC, PCMB
2006 — 2008
Birla Institute of Technology and Science, Pilani
Master of Business Administration - MBA, Quality Management
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