Junior Product Registration Specialist PRS

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 opportunity 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 procedures and regulatory requirements. Candidate Requirements Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related field. 2 to 6 years of experience in Regulatory Affairs, Product Registration, Quality Assurance, or a related function within the Medical Device or IVD industry. Basic understanding of regulatory frameworks such as MDR, IVDR, FDA regulations, and international product registration requirements. Experience supporting regulatory submissions and maintaining regulatory documentation is preferred. Familiarity with document control systems, electronic quality management systems (eQMS), or digital submission platforms is an advantage. Strong written and verbal communication skills. Good technical writing and documentation skills. Strong attention to detail and organizational skills. Ability to manage multiple tasks and meet deadlines in a fast-paced environment. Proficiency in Microsoft Office applications, particularly Word, Excel, and PowerPoint. Eagerness to learn and develop expertise in global regulatory requirements and product registration processes. Preferred Qualifications Exposure to Medical Device or IVD regulatory submissions. Knowledge of ISO 13485, MDR, IVDR, or FDA regulatory requirements. Experience working in a regulated environment. Regulatory Affairs certification or training is an added advantage