Junior Product Registration Specialist (PRS)
Experience: 2 to 6 Years
Work Mode: Hybrid
Location: Bengaluru
About the Role
We are seeking a motivated Product Registration Specialist to support global regulatory activities for In Vitro Diagnostics (IVD) and Medical Device products. The role involves assisting with product registration submissions, maintaining regulatory documentation, coordinating with cross-functional teams, and supporting compliance activities across global markets. This is an excellent prospect for professionals looking to build expertise in global Regulatory Affairs.
Responsibilities
Support the preparation, compilation, review, and submission of regulatory dossiers for product registrations, renewals, and amendments across global markets.
Assist in the execution of regulatory strategies for IVD and Medical Device products under applicable regulations and regional requirements.
Maintain submission trackers and support the end-to-end submission process, including document collection, gap assessments, and response coordination.
Collaborate with Quality, R&D;,
Manufacturing, and other cross-functional teams to obtain required documents and information for regulatory submissions.
Support interactions with regulatory authorities, notified bodies, and regional affiliates by preparing responses and documentation as required.
Maintain accurate and up-to-date regulatory records, databases, and document management systems.
Assist in reviewing product labeling, IFUs, and related documentation for regulatory compliance.
Support product change assessments and regulatory impact evaluations.
Contribute to post-market regulatory compliance activities and regulatory surveillance.
Track regulatory commitments, approvals, and registration renewals to ensure timely compliance.
Participate in process improvement initiatives related to regulatory documentation and submission management.
Ensure proper documentation practices are followed in accordance with company p