Medical Device Quality Assurance

Bindiya Patel

413-***-**** *******.**@*******.*** 1032 Riverdale St, W. Springfield, MA. 01089

OBJECTIVE: To secure a position specializing in Regulatory affairs, in order to apply skills,

expertise and talents in exchange for career guidance, training, and opportunity for advancement

EDUCATION:

College of Professional Studies, Northeastern University, Boston, MA, USA Dec 2012

Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices cGPA: 3.5

Relevant Coursework

New Drug Development: A QA/Regulatory Medical Device Development: A

Overview QA/Regulatory Overview

Human Experimentation: Methodological Food, Drug & Medical Device Law

Issues Practical aspects of Regulatory Compliance

Biologics Development: A QA/Regulatory International Regulatory Affairs

Overview Dimensions of Orphan Drugs

University Of Toronto, Mississauga, Ontario, Canada Apr 2011

Honors Bachelors of Science: Specialization Biotechnology

WORK EXPERIENCE:

Wal-Mart July, 2011-

Present

Assistant Manager / Merchandise Supervisor Northampton,

MA

• Drive Sales and financial performance in assigned areas

• Developed and maintained quality assurance program in the store for food products through

product regulations such as grading, COOL labeling, and related compliances.

• Analyze and interpret reports, implement and monitor asset protection and safety controls,

overseeing safety and operational reviews, developing and implementing action plans to correct

deficiency, and provide direction on executing company program and strategic initiatives

• Provide supervision and develop opportunities by hiring, training, mentoring, assigning duties,

evaluating performance, recognizing and ensuring diversity awareness.

• Managing vendor and consumer relations and satisfaction.

Vital-Link Inc. May, 2008-

Dec, 2010

Supervisor & Quality Control Toronto,

Ontario

• Inspected processes and procedures to ensure good health and safety practice

• Responsible for planning, setting up, executing and tearing down events

• Developed and maintained quality assurance program to ensure food quality and adhere to SOP

• Ensured appropriate product holds at certain temperature and dispositions according to

approved SOP

Bindiya Patel

413-***-**** *******.**@*******.*** 1032 Riverdale St, W. Springfield, MA. 01089

• Performed administration work including weekly stock, consumption account, making

schedule, preparing invoices, receiving and sending deliveries, documentation, organizing, etc.

University of Toronto Oct, 2008- Mar, 2009

Database Coordinator Mississauga,

Ontario

• Obtain and process information for developing protocols for phenotypic investigation

• Creating database for the designed protocols using MS Office

• Used several assessment and analytical tools to analyze the data qualitatively and quantitatively

• Analyzed raw data, drawing conclusions & developing recommendations

• Testing and running the experiments for the developed protocols.

ACADEMIC PROJECTS:

• Designed Regulatory Development Plan for “fictitious New Drug”

• Prepared outline of Regulatory submissions for NDA according to ICH CTD Module

• Identified regulatory pathway and drafted a “traditional 510(k)” outline for Medical Device

• Designed regulatory pathway for market approval of Combination product

• Designed regulatory pathway and drafted outline for “Abbreviated 510(k)” for Medical Device

SKILLS

Regulatory skills:

• Proficient understanding of IND, NDA, BLA, ANDA, IDE, 510 (k), PMA processes

• Knowledge of technical documents like eCTDs and STEDs

• Knowledge of regulations and standards including FDA/USDA, Health Canada, cGMP, SOPs,

cGCP, ICH guidelines and ISO standards

• Sharpened understanding of the laws that govern the development, manufacturing, and

commercial distribution of food, drugs, biologics, and medical devices

• Gained familiarity with regulatory legislation in Health Canada, EMEA and MHLW, in addition

to US FDA and other international bodies like Therapeutic Goods Administration (Australia).

Computer skills:

• Proficient Windows and Macintosh user, with expertise in MS Office, Adobe, Scientific

research and Web browsing.

ACHIEVEMENTS

• Certified Food Safety Manager by National Registry of Food Safety professionals, USA.

• Food handling certificate offered by Toronto Public Health, Canada.

• Volunteer certificate for Brain Day 2010 from Think First foundation of Canada.

• Volunteer certificate for 30th Annual Association for Biology Laboratory Education (ABLE)

Conference hosted by the Department of Biology at the University of Toronto at Mississauga.

Bindiya Patel

413-***-**** *******.**@*******.*** 1032 Riverdale St, W. Springfield, MA. 01089

(Reference available upon request)

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