CURRICULUM VITAE: AMI A.

JARIWALA

CAREER OBJECTIVE

A career with a progressive organization where I can always learn new things and utilize my skills and
potential of being a part of Regulatory Affairs. To be an asset to the company and help the company
so that it attains the height of success by my dedication and perseverance.

TECHNICAL SKILL AND EXPERIENCE

 INDIAN FDA KNOWN AS DRUG CONTROLLER GENERAL INDIA (DCGI):

- Manufacturing License for Medical Device
- Additional Product Manufacturing Permission
- Import Registration and License for Medical Device and Drug
- Test License Application to Import Product for Examination, Test & Analysis
- Extension of Stability for Approved Products

 CERTIFICATION OF QUALITY MANAGEMENT SYSTEM:

- New or Renewal of latest ISO 9001 Certification from Notified Body
- New or Renewal of latest ISO 13485 Certification from Notified Body

 EUROPEAN CONFORMITY (CE) FOR MEDICAL DEVICE

- Technical File or Design Dossier Preparation in compliance of Medical Device Directive MDD
93/42/EEC amended by 2007/47/EC
- Design File in compliance of latest ISO 9001 or ISO 13485
- Labeling and Instruction for Use (IFU) in compliance of applicable standards
- Risk Management in compliance of latest ISO 14971
- Clinical Evaluation in compliance of Latest MEDDEV 2.7.1

 INTERNATIONAL PRODUCT REGISTRATION FOR EXPORT OF MEDICAL DEVICE

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 CURRICULUM VITAE: AMI A. JARIWALA

EDUCATIONAL QUALIFICATION

Subject Academic Year University / Board Percentage

T.Y B. Sc. (Chemistry) 2005 Veer Narmad South 63 %
S.Y B. Sc. (CP) 2004 Gujarat University 67 %
F.Y B. Sc. (CPB) 2003 (VNSGU) 69.70 %
H.S.C 2002 GHSEB, Gandhinagar 53.75 %
S.S.C 2000 GSEB, Gandhinagar 78.72 %

 Additional Industrial Course:

1. Industry Program in Pharma Regulatory Affairs
2. General Course on Intellectual Property of WIPO (World Intellectual Property Organization)

RESEARCH STUDY DURING COURSE

1. Drug Master File Preparation & Maintenance as per European & US FDA Guidelines.

TRAINING & WORKSHOPS

1. Certification of Internal Quality Audit Training organized by Notified Body Det Norske Veritas As.
2. Certification workshop on electronic Common Technical Documents (eCTD) organized by
PharmaReady Company.

ACKNOWLEDGEMENT IN PUBLICATION

1. Arpit Jariwala, Chhaya Engineer, HareshKotadia, AnkurRaval and DeveshKothwala, New

Generation Sirolimus Eluting PTCA Angioplasty Balloon Catheter for Restenosis Therapy.
Trends in Biomaterials and Artificial Organs; Vol 22 (2) (2008): 83-88 (2008).

AREAS OF INTEREST

 Quality Management System’s Document of Company

 Technical Submission for National and International Product Approval & Registration

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 CURRICULUM VITAE: AMI A. JARIWALA

PERSONAL PROFILE

105, 4th Street, Krushnakunj Society,

Near BSNL Office,
Permanent Address Palanpur Patia,
Surat–395005,
Gujarat, India
Contact Number +918485957309, +918320307023
Email fusion.mdcra@gmail.com
Date of Birth 24th June, 1984
Gender Female
Known Languages English, Gujarati, Hindi
Hobbies Net Surfing, Listen soft Music & Drawing
Marital Status Married

EXPERIENCE

Field: Regulatory Affairs (RA) of Medical Device Industry

Experience: July 2005 to till date (14+ years of Experience in field of RA)
Sahajanand Medical Technologies Pvt. Ltd. (Cardiovascular Company)
(July 2005 to Nov, 2011)
Concept Medical Pvt. Ltd. (Cardiovascular Company)
(Dec, 2011 to May, 2014)
Independent: Proprietor of Fusion Consultant (June, 2014 to till date)
RA Head of Matrix Meditec Pvt. Ltd. (Orthopedic Company)
(June, 2014 to till date)
RA In-charge of Gel Biotech Pvt. Ltd. (Dental Company)
(June 2016 to Dec, 2017)
Complete more than 10 Import Registration & License of Notified Medical
Devices of various companies in CDSCO.

Best regards,
Ami Jariwala

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