Senior Process Executive with 4 Years 8 Months experience in Medical Device Quality Assurance Complaint Investigation Department as an Investigator. Seeking a challenging and career advancing position.
5
years of professional experience
Work History
Senior process Executive
3 Years 6 Months
Cognizant Technology Solutions | Kolkata | 04.2023 - Current
Conducted medical device reporting (MDR), reportable submission, investigation, and evaluation processes to ensure accurate compliance.
Processed regulatory submission cases while ensuring compliance with applicable global regulatory guidelines and internal SOPs.
Coordinated data management and post market surveillance (PMS) activities to enhance regulatory compliance.
Streamlined data collection for regulatory compliance, improving organization and accessibility.
Provided quality assurance of medical device complaints.
Ensure, Validate and Document all the data in the Complaint that matches the data in the Device History Report (DHR) from Third Party Manufacturers (TPM).
Process Development and Validation Scientist at Alora pharmaceuticals - Osmotica PharmaceuticalsProcess Development and Validation Scientist at Alora pharmaceuticals - Osmotica Pharmaceuticals