Regulatory Affairs Specialist
Preparation and timely completion of product registrations for In vitro diagnostic devices as per Medical Devices Rules (MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) , EU-CE IVD & US-FDA.
Responsible for assessment and applicable documentation of changes in product, manufacturing processes, labelling affecting IVD products distributed in India/EU Market., support regulatory teams and/or in-country dealers/representatives with regulatory registrations of manufactured IVD products. Submission of Dossiers to Regulatory Authorities & NB for maintenance of Licenses & QMS Certification. Understand the regulatory requirements from perspective of tenders & ensuring compliance to the requirements. Support all activities of the Regulatory Product Release system (product classification, set up of licences, documentation, training etc.) and preparation of WHO Pre-qualification submission documents for the manufactured IVD products. Regularly following up with CDSCO for import license of IVD devices and medical devices regulated under Medical Devices Rules 2017 and submission of applications, clarifying to queries, registration of products with Tamil Nadu State FDA.
Bio-Medical Engineering/M Pharm/ MSc Life Sciences with 4+ years of experience. Good understanding of regulations and policies issued by Indian CDSCO, US FDA and EU.
Good to have skill
Handled Performance Evaluation of In vitro diagnostic kits/reagents as per Indian MDR 2017. Excellent written, organizational, and communication skills are required.