Office Medical Device

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Avani Barot

Regulatory Affairs Administrator, Bracco Diagnostic Inc. ************@*****.*** 917-***-**** Summary

I am an experienced Regulatory Affairs Administrator with a demonstrated history of working in the Dental and Medical Device industries. Strong administrative professional skilled in Business Planning, Medical Devices, Medication Administration, Foreign Languages, and Team Building. One of my reasons for coming into the field of Regulatory Affairs is because it is a platform that is constantly evolving, adapting itself to the requirement of the industry, and to be able to work in an environment that constantly brings up new challenges can be rewarding and exciting. Experience

Bracco Diagnostic Inc. April 2018 – Present

Regulatory Affair Administrator

Responsible for application of thorough understanding for manufacturing requirements, processes and compliance

Review/Assist in the regulatory procedures, internal organizational audits, inspections, license renewals, and product registration.

Review the labeling, promotions, and advertising materials to ensure Regulatory Compliance.

Responsible for monitoring and maintenance of medical device reference standards, regulations, and guidance documents.

Reviewed and revised standard operating process (SOP) for external standard management and implemented a Standards surveillance system in the company to record standard modifications.

Responsible for creating product profiles on the BSI’s Compliance Navigator web-engine.

Responsible for scrutinizing new regulations of EU-MDR, assess its impact on BDI products and implementing compliant processes and procedures accordingly.

Responsible for the preparation and submission for new Regulatory filings; file amendments/updates: 510(k), sNDA, and European Technical Files

Assisted in the implementation of EU mandated Unique Device Identification (UDI) requirements.

Assisted in compiling Risk management plan and risk management report for 510(k) submission.

Responsible for reviewing and updating material composition documents for the ‘DEHP removal project’

Responsible for providing up-to-date regulatory information, inclusion of domestic and international regulations.

Henry Schein January 2018 – March 2018

Internship: Regulatory Affairs Associate

Responsible for filing license registration applications, composing cover letters and efficiently communicate to the Regulatory authorities.

Responsible for conducting Denied Party Screen using Office of Foreign Asset control’s (OFAC) lists.

Review product development data to ensure data meet the FDA standards.

Review Clinical protocol to assure collection of appropriate data for Regulatory Submission and Regulatory Compliance.

Monitor and self-educate Regulatory laws of the FDA and international regulatory systems: JPMA, Health Canada, EMA, TGA, and SFDA through websites and publications Page 2

Brooklyn Family Dental June 2015 - December

2017

Office Manager

Create, establish and manage internal office protocols and procedures to ensure office efficiency

Hire and train new office staff to respond to patients’ needs and manage billing systems

Greet and serve all patients as they arrive (or direct other staff to do same)

Maintain the dental clinic’s budget, general ledger and accounting systems

Motivate office personnel to serve patients

Oversee the processing of insurance and secondary insurance claims

Assist patients with applying for credit and other financial assistance

Provide the Dentist with administrative and practical support when asked Research Assistant at Stony Brook University January 2015 - June 2015

Performing routine clerical duties as instructed, essential to the research activities of the supervisor and project investigator.

Supervise the undergraduate students working along in the assigned research projects

Gather and analyze data vital for research

Assisted with academic research, Cancer research and care

Assisted in the discovery of potential Cancer Biomarker

Assisted in monitoring cancer biomarkers during the treatment Education

The Johns Hopkins University

Master of Science (MS), Regulatory Science, January 2017 – May 2018 Stony Brook University

Bachelor’s Degree, Biology, General, September 2010 – May 2015 Training & Certification

Good Regulatory Practices, GXP’s (GCP, GLP, GMP).

Prepare for IND, NDA, ANDA, and API DMF submissions.

Prepare for 510(k), PMA, and MDD submissions.

Prepare and submit documentation required for Veterinary Pharmaceuticals and Veterinary Biologics to USDA’s CVB.

Prepare required documents for US and International facility registration, EMA, Health Canada, and JPMA

e-CTD workshop for submission of drugs, biologics and combination products.

EU-MDR transition from MDD for medical devices.

Skills

MS Office (Word, Excel, PowerPoint, Outlook), Outlook express, Bridger software, Expresso, Adobe Acrobat, Google suit, and Asana

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Organization

Member of the Regulatory Affairs Professional society (RAPS) Volunteer at Regulatory Affairs Professional society (RAPS)

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