Rohit Uniyal
Senior Manager Regulatory Affairs @DSS Imagetech Pvt Ltd
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WORK HISTORY
Senior Manager Regulatory Affairs @DSS Imagetech Pvt Ltd
New Delhi, IN
EDUCATION
Siddhartha Institute of pharmacy
Bachelor of Pharmacy (B.Pharm.)
Modern Institute of Technology, Dhalwala, Rishikesh
D.Pharm
Uttrakhand Technical University
Master's degree in Pharmacy, Pharmacology
SKILLS
ABOUT ROHIT UNIYAL
12 year\'s Rich experience in regulatory affairs. Responsible for registration of Medical Device (Import) in India •Documentation needed for Registration/Re-registration of medical device as per Medical Device Rules, 2017.•Preparation of Device Dossiers, Site Master Files, Timely Updating of trackers •To deal with the domestic regulatory authorities like CDSCO, NPPA, BSI etc.•Knowledge of Standards as per CE, ISO certification (ISO 13485, Annex II.3, Annex II.4) •To provide support to International Marketing team in terms of latest regulations and its implementation to have total regulatory compliance in Sri Lanka. Bangladesh and Nepal. •Work closely with International Dealers to provide support in terms of regulatory requirements •Knowledge about Indian Regulatory Guidelines •To Support operation and marketing teams to fulfill product shipment
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