Microsoft Office
Nirav Harshadbhai Bulsara
Regualtory Affairs Specialist
B/203, Suramya Residency, Near R.P.F. Ground, T.V. Relay Kendra Road, Valsad,GJ
Summary
Performance driven, problem solver and team player with 9 years of experience in dealing with Indian FDA, CE certification and other regulatory requirements.
Overview
3
3
Languages
8
8
Certificates
11
11
years of post-secondary education
9
9
years of professional experience
Work History
Senior Executive
Meril LIfe Sciences Private Limited
Vapi, Gujarat
05.2012 - Current
- Prepare, review and update Technical Master File for CE submission in European Union.
- Prepare, review and update Device Master File for Medical device and IVDs for submission in Indian FDA as per Medical Device Rules 2017.
- Prepare, review and update of Device Design History Files.
- Prepare, review and submit the Technical Dossier for various types of applications i.e. Wholesale license, Test license, Manufacturing license, Import license, Registration certificate, Clinical trial etc. as per time line on online portal "SUGAM".
- Obtain quality certificates like Production Capacity / Market Standing / Performance / Non-Conviction etc. for taking part in various tenders.
- Obtain certificate like Free Sale certificate and Neutral code approval for export purpose.
- Maintain and ensure document control systems and its adherence to applicable standards i.e. ISO 13485, 21 CFR, B-GMP, CAN/CSA-ISO 13485.
- Co-ordinate during audits from Notified bodies as well as CDSCO/FDA related to product and facility.
- Co-ordinate with Development, Production, QA/QC department for documentation required for filings of response to audit's non compliance.
- Liaison with Local (Valsad), State (Gujarat) as well as Central FDA (Delhi & Ahmadabad) for Technical discussion regarding product permission of medical devices as well as IVDs.
- Timely updates about any routine changes and update in Quality Manual, Site Master File, Technical Master File, Quality Procedure etc.
- Communicate and coordinate with regulatory personnel of different companies abroad for compilation of various documentations required for registration of their product meant to be imported in India.
- Prepare Risk Management report as per ISO 14971, Clinical Evaluation report, Essential Safety Requirement etc. as per requirements by coordinating with Development, Production & Quality Control departments and performing literature reviews.
- Co-ordinate with various departments for configuration of online Quality Management System i.e. Matrix QMS system.
- Vigilant for regulatory change being happened and their effect to the business.
Education
Master of Business Administration - Operations Management
Sikkim Manipal University
Gangtok 11.2011 - 11.2013
Bachelor of Engineering - Electronics And Communication
Charotar Institute of Technology
06.2006 - 06.2010
Higher Secondary School Certificate - Science Education
St. Joseph’s E.T. High School (Gujarat Board)
Valsad 04.2004 - 03.2006
Secondary School Certificate - General Studies
St. Joseph’s E.T. High School (Gujarat Board)
Valsad 04.2001 - 03.2004
Skills
Team Player
Software
SUGAM Portal
Matrix QMS
Hobbies
Walking
Cycling
Gardening
Certification
Microsoft Office certified by Aptech Computer Education
Timeline
Certified for participating in virtual Cyclothon 2021 organized by Sports Authority on India
01-2021
Certificate of Completion of Regulatory Affairs course sponsored by Udemy
10-2020
Certified for various online courses i.e. Business Etiquette, Communication Skills, Email Etiquette, Group Discussion, Soft Skills, Presentation Skills, Telephone Etiquette etc offered by TCS iON.
10-2020
Certified for participating in Fit India Freedom Run organized by Government of India
08-2020
Participated in Cricket Tournament organized by Meril Life Sciences Pvt. Ltd., Vapi.
05-2016
Senior Executive
Meril LIfe Sciences Private Limited
05.2012 - Current
Master of Business Administration - Operations Management
Sikkim Manipal University
11.2011 - 11.2013
CCNA certified by IANT
11-2010
Programming in C & C++ certified by Databank Computer Education
07-2006
Bachelor of Engineering - Electronics And Communication
Charotar Institute of Technology
06.2006 - 06.2010
Microsoft Office certified by Aptech Computer Education
07-2004
Higher Secondary School Certificate - Science Education
St. Joseph’s E.T. High School (Gujarat Board)
04.2004 - 03.2006
Secondary School Certificate - General Studies
St. Joseph’s E.T. High School (Gujarat Board)
04.2001 - 03.2004
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