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Asikha Dilkash

@asikhadilkash

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Dedicated Regulatory Affairs Analyst with expertise in data analysis.

India

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What I'm looking for

I am looking for a role that allows me to utilize my regulatory compliance expertise and analytical skills in a collaborative environment focused on improving healthcare outcomes.

I am a dedicated Regulatory Affairs Analyst with over 3.3 years of experience in the healthcare industry, specializing in complaint handling and regulatory compliance. My journey began as a Biomedical Engineer, where I developed a strong analytical mindset and a passion for ensuring the safety and effectiveness of medical devices. I have successfully collaborated with cross-functional teams to navigate complex regulatory landscapes, ensuring that products meet industry standards and regulations.

At HCL, I have honed my skills in preparing regulatory documents for health authorities, conducting comprehensive reviews of product labeling, and implementing strategies for successful regulatory submissions. My proficiency in Microsoft Excel, PowerPoint, and Word, along with my experience in data enrichment and analysis, allows me to drive efficiency and success in the healthcare sector. I am now seeking a Healthcare Analyst position where I can leverage my expertise to contribute to impactful projects.

Experience

Work history, roles, and key accomplishments

Information Analyst - Regulatory Affairs

HCL JNJ

Mar 2021 - Present (4 years 3 months)

Handled complaints for Jnj Power tools products and previously worked on BD Alaris Infusion Pumps for the USA region under FDA regulations. Interpreted regulatory guidelines to ensure compliance with industry standards and regulations.

Complaint Handling Data Analysis Microsoft Excel PowerPoint Word Magical AI JavaScript Selenium SAP

MDR Regulations, LABELLING

HCL

Nov 2018 - Present (6 years 7 months)

Managed MDR regulations, labeling for user manuals, regulatory affairs, and gap assessments for Baxter, HillRom, and Teleflex. Created user manuals and performed data enrichment processes.

Regulatory Affairs Data Enrichment

DATA ENRICHMENT

Firstsource Private Limited

Feb 2012 - Present (13 years 4 months)

Managed the process of providing details of medical instruments to client websites using a PDM tool. Developed and implemented data enrichment strategies to enhance accuracy and completeness of information.

Data Enrichment Data Validation

Biomedical Engineer

Cosh Hospital

Jan 2011 - Present (14 years 5 months)

Collected patient data and history files, and provided patient details to doctors. Conducted research and experiments to evaluate the safety and effectiveness of medical devices and technologies.

Research Experimentation

Biomedical Engineer

Avm Hospital

Mar 2010 - Present (15 years 3 months)

Collected patient data and history files, and provided patient details to doctors. Conducted research and experiments to evaluate the safety and effectiveness of medical devices and technologies.

Research Experimentation

Education

Degrees, certifications, and relevant coursework

Not specified

Biomedical Engineer, Biomedical Engineering

Asikha Yasmeen J PmsAnalyst Complaint handling, Data analyst, Mdr regulatory affairs, Gap assessment, labelling, instrumentation and Decision making. Dedicated Regulatory Affairs Analyst with proficiency in Microsoft Excel, PowerPoint, and Word. Skilled in Magical AI learning and JavaScript automation using Selenium. Seeking a Healthcare Analyst position to utilize my expertise in regulatory compl