Regulatory Affairs Associate

HETAL PATEL

**** *. ***** ******* ****., Anaheim, California-92806.

******************@*****.*** +1-631-***-****

SUMMARY

Detail-oriented graduate biomedical engineer with MBA in marketing, seeking regulatory specialist role in medical device industry. With strong understanding of FDA, EU and regulatory requirements, committed to meet deadlines in timely manner. Ability to lead cross-functional teams and have strong cooperative communication skills. Preparing for RAC through RAPS.

PROFESSIONAL EXPERIENCE

SALES RELATIONSHIP OFFICER MAY 2012-AUGUST 2013 EXTRAMARKS EDUCATION PVT. LTD., INDIA

Member of sales and marketing team for brand building.

Conducted research for future market opportunities of digital education in Gujarat region.

Enhanced brand awareness in approximate one year.

RESEARCH ANALYST Dec 2010-JUNE 2011

RCAD SOLUTIONS, INDIA

Research on “Study of Potential of Pro-E Software in Ahmedabad City, India”.

Field visits and marketing of Pro-E software.

Analysis of data using SAS.

BIOMEDICAL ENGINEER (INTERN) Dec 2009-MARCH 2010

GUJARAT CANCER AND RESEARCH INSTITUTE, INDIA

Team member of research on “Risk Factors for Breast Cancer in India”.

Assisted biomedical engineering team at physiotherapy department and neurology department.

Assistant for orthopedic technician.

Worked in quality department as assistance for vendor evaluation and supplier quality assessment. complaint handling, documents and calibration controls.

EDUCATION

MASTER OF SCIENCE IN BIOMEDICAL ENGINEERING GPA: 3.5/4.0

NEW JERSEY INSTITUTE OF TECHNOLOGY, NEWARK, NEW JERSEY GRADUATED: DEC 2016

MASTER OF BUSINESS ADMINISTRATION IN MARKETING GPA: 3.5/4.0

SHREE CHIMANBHAI PATEL INSTITUTE OF MANAGEMENT, INDIA GRADUATED: MAY 2012

BACHELOR OF ENGINEERING IN BIOMEDICAL ENGINEERING GPA:3.3/4.0 GOVERNMENT ENGINEERING COLLEGE, INDIA GRADUATED: JUNE 2010

RELEVENT COURSES

MEDICAL DEVICE DEVELOPMENT-WITH FOCUS ON REGULATORY DEPARTMENT ACTIVIES

INTRODUCTION TO BIOMECHANICAL ENGINEERING

BIOROBOTICS

COMPUTER METHODS IN BIOMEDICAL ENGINEERING

SYSTEM MANAGEMENT FOR MEDICAL DEVICES

PRINCIPLES OF NEUROMUSCULAR MECHANICS

CAD FOR BIOMECHANICS AND BIOMATERIALS (PTC CREO)

TECHNICAL AND ADDITIONAL SKILLS

Matlab Windows OS

C-Programming Minitab

LabVIEW Market Research

PTC Creo Business and Brand Development

Optitrack Team Management

SAS (Stat.) Marketing Communication

MS Office Sales and Branding

ACADEMIC PROJECTS

Role-Project Manager

Designed unique NICU incubator to enhance safety of infants and to reduce electro pollution in surrounding area of infants. Maintained a team for new product development and submitted DHF with needed design controls.

Designed Graphical User Interface (GUI) in Matlab for auditory (hearing) rehabilitation and speech processing.

Designed a novel approach for manual wheelchair design.

RESEARCH PAPER

Photo and Magneto Acoustic Imaging.

Submitted to Dr.Sahin Mesut for course requirement.

REVIEW ARTICLE

A Review on Cognitive Rehabilitation and Multiple Sclerosis.

Submitted to Dr.Sergei Adamovich for course requirement.

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