Role & responsibilities
Manage end-to-end CDSCO regulatory projects for Medical Devices and Cosmetics.
Handle CDSCO registrations, import licenses, manufacturing licenses, permissions, and other regulatory approvals.
Review technical documentation and ensure compliance with applicable CDSCO regulations.
Prepare, verify, and submit applications through the CDSCO SUGAM Portal.
Coordinate with clients to collect, review, and validate regulatory documents.
Follow up with clients regarding pending documents and approvals.
Monitor project timelines and ensure timely completion of all assigned projects.
Liaise with CDSCO officials, testing laboratories, manufacturers, and other stakeholders whenever required.
Stay updated with changes in CDSCO guidelines, Medical Devices Rules, Cosmetics Rules, and other applicable regulations.
Work closely with the Business Development team to provide technical support during client discussions whenever required.
Preferred candidate profile
Robust knowledge of CDSCO regulations and regulatory procedures.
Hands-on experience with the CDSCO SUGAM Portal.
Excellent knowledge of Medical Devices Rules, 2017.
Valuable understanding of the Drugs & Cosmetics Act, 1940 and related Rules.
Solid documentation review and regulatory compliance skills.
Project management and team leadership abilities.
Excellent communication and client coordination skills.
Ability to manage multiple regulatory projects simultaneously.
Proficiency in Microsoft Office (Excel, Word, Outlook).