REGULATORY AFFAIRS SPECIALIST
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Total work experience of 7+ years in the Medical device industry.
I started my career as a Biomedical Engineer and had experience in the Installation and commissioning, handover, maintenance and sales of medical equipment.
Participation in NABH auditing, documentation as per NABH standards etc.,
Then I stepped into a new arena of medical device regulatory with HCL technologies and learned much about Design control, Design History files, Design Verification, Risk
Management, and Process Validation.
Strong abilities in Product development activities like Design Inputs & Outputs, Usability studies, Verification and Validation, Risk analysis and related documentation.
Familiar with the transition of technical files from MDD to MDR (EUMDR 2017/745 ) .
Product Lead, MDD to MDR Transition.
Creating/Updating Design Control Files, Technical files, GSPR & Risk management documents to meet regulatory requirements.
Responsible to meet the MDR compliance and CE Marking of current MDD Certified products.
Risk analysis based on EN ISO 14971 and the risk management file will be updated by mitigating the findings.
Creating Gap Assessment and Remediation Plan.
Creating a Human factor summary report in accordance with IEC 62366.
Conducting Final Design Review.
DHF Remediation activities, Design Input/ Output Documents – Design Review.
Executing Verification & Validation Plan and Summary Report.
Executing Trace matrix document.
Dossier Preparation.
Handled Client Calls - Product Support.
Compliant Handling and CAPA.
Leading the CCP (Change control project), involved identifying potential change type & its impact i.e., Assessing if the change has any impact on product performance or design, Risk
Management documents, Raw material specs, manufacturing process & documents, etc.
Handling Training Sessions.
Did my graduation in BIO MEDICAL INSTRUMENTATION ENGINEERING
