Farheen Taj
Regulatory Reporting Specialist @Akkodis
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WORK HISTORY
Regulatory Reporting Specialist @Akkodis
US
Draft and submit MedWatch 3500A reports for Class medical devices like urology, interventional radiology, reproductive health and critical care to the US FDA, ensuring compliance with 21 CFR 820. Prepare and submit EU MDR reports per ISO 13485 and ISO 14971 standards.•Conduct initial evaluations of device complaints to determine reportability, ensuring compliance with regulatory standards. Performing 25-day sweeps to prevent correction reports and ensure timely compliance with global regulatory requirements.
EDUCATION
Rajiv Gandhi University of Health Sciences
Bachelor's of dental surgery, Dentistry
ABOUT FARHEEN TAJ
Experienced Regulatory Affairs Professional with 6+ years in Pharmacovigilance and…
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