16 Sep
|
OSI Systems
|
Madhapur
16 Sep
OSI Systems
Madhapur
Overview
The Senior Regulatory Affairs (RA) Specialist supports the regulatory and product registration activities of the company globally including India, the Asia Pacific region, and the Middle East. This RA Specialist role requires a professional who will work closely with high priority regulatory activities such as CDSCO import licences and associated registrations activites in India, and product registration in Australia, Saudi Arabia, the United Arab Emirates, Singapore, Malaysia, the Philippines, and Thailand. The RA Specialist will provide regulatory feedback in order to facilitate the launch of current products in the region and work with the design control teams to assess for regulatory impact of product changes. This RA Specialist will provide technical guidance to cross functional teams for submission preparation and interaction with regulatory agencies, in-country representatives, and distribution partners.
Responsibilities
• Coordinate, author, and prepare regulatory submissions, including CDSCO import licence applications (Form MD-14/MD-15)
and registration certificates, Australian TGA ARTG inclusion applications, Saudi FDA Medical Device Marketing Authorization (MDMA) applications, UAE MOHAP registrations, Singapore HSA product registrations, Malaysia MDA registrations, Philippine FDA Certificates of Product Registration, Thai FDA licences, and/or other documentation required for registration/licensure of products across the Asia Pacific and Middle East regions.
• Serve as a strategic business partner with business clients to proactively develop and implement practical, compliant regulatory plans, and delivering timely, effective business solutions to quality and regulatory issues.
• Respond to regulatory agency requests and obtain necessary premarket approvals, registrations, and/or licences from health authorities across the India, Asia Pacific, and Middle East markets.
• Provide general support to the RA/QA department in regulatory-related matters.
📌 Sr. Regulatory Affairs Specialist (Madhapur)
🏢 OSI Systems
📍 Madhapur