CURRICULUM VITAE: AMI A.

JARIWALA

CAREER OBJECTIVE

Seeking 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 (Form 28)
- Additional Product Manufacturing Permission (Addition in Form 28)
- Import Registration for Medical Device and Drug (Form 41)
- Import License for Medical Device and Drug (Form 10)
- Test License Application to Import Product for Examination, Test & Analysis (Form 11)
- Extension of Stability for Approved Products
- Good Manufacturing Practices
- Equipment and Process Validations

 STATE FDA:
- Plan approval or modification application
- Manufacturing permission of product for examination, test or analysis
- Free Sale Certificates

 CERTIFICATION OF QUALITY MANAGEMENT SYSTEM:

- New or Renewal of ISO 9001: 2008 Certification from Notified Body
- New or Renewal of ISO 13485: 2003 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 ISO 9001: 2008 or EN ISO 13485: 2012
- Labeling and Instruction for Use (IFU) in compliance of applicable standards
- Risk Management in compliance of EN ISO 14971: 2012

 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 & Maintenanceas per European& in 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

4/4225, Bhula Modi ni Pole,

Begumpura,
Permanent Address
Surat-395003,
Gujarat, India
105, 4th Street, Krushnakunj Soc.,
Near BSNL Office,
Correspondence
Palanpur Patia,
Address
Adajan, Surat–395009,
Gujarat, India
Contact Number +918485957309, +919426012702
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 of Medical Device Industry

Experience: July 2005 to till date
Previous employment: Sahajanand Medical Technologies Pvt. Ltd. (July 2005 to Nov, 2011)
Envision Scientific Pvt. Ltd. (Dec, 2011 to May, 2014)
Independent: RA Consultant for Fusion Consultancy (June, 2014 to till date)

Best regards,
Ami Jariwala

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