Tamal Saha

• Manages the complete life cycle of medical device complaint resolution, thoroughly evaluating each case for precise categorization and appropriate resolution.
• Spearheads technical investigations into product anomalies, engaging collaboratively with service centers and quality assurance departments to ascertain causal factors, and institute remedial measures.
• Prepares and systematically archives essential regulatory submissions, including forms 3500A, MIR, and Health Canada documentation, within the dedicated Luna Salesforce database.
• Meticulously reviews potential adverse event scenarios to ensure absolute compliance with FDA reporting requirements (21 CFR 803).
• Maintains oversight of the global medical device complaint management framework, utilizing insights from customer feedback and service records for continuous product enhancement, and compliance optimization.

Conducts instructional sessions and disseminates current regulatory amendments pertaining to medical devices to team members, ensuring uniform comprehension and adherence.