senior regulatory analyst
Hcl Technologies
Total years of experience :3 years, 3 Months
PRODUCT REGULATORY ANALYST
Technical documentation of STED, GSPR, APR, PEP, PER, SVR and CPR in compliance with EU IVDR 2017/746 regulation.
Gap analysis, Clean-up and redlining of technical and supporting documents
Expertise in systemic literature review of IVD Medical devices.
Performed complaint intake, assessment using decision tree, follow-up, closure activity and Mailbox Management.
Drafted Acceptance Email, Acknowledgment Letter and customer response letter for the product complaints.
Expertise in Trackwise, Salesforce, Smax, Deepl, Ms Tools.
Standards Known: ISO 13485, ISO 14971, ISO 15223, ISO 20916 and IEC 62304.