Regulatory Affairs Specialist

Job Description

Responsibilities: Primary Responsibilities: 1. Regulatory Filings and Compliance of regulatory documents: • Coordinating for planning and execution of device regulatory submissions and all other regulatory related activities, globally • Responsible to assist in activities of authoring, review, submission of device related sections of different combination products • Responsible for preparing the response and submission for any agency queries information request on device activities. • Responsible for ISO 13485/ CE certification audit compliance pertaining to regulatory activities and contributes towards post audit management. • Responsible for device related sections in post approval variation submission of different combination products. • Responsible for preparing the technical files and getting NBOp as per article 117 of EU MDR (2017/745) • Ensuring compliance with GSPR as per Annexure I EU MDR (2017/245) • Responsible for activities associated to the devices, in the dossier preparation for biosimilar product under BLA/IND/MAA and perform review, as required. • Coordinating with partners, customers and authorities for dossier finalization, query response and submission as required. • Responsible for device regulatory related SOPs revisions/update as required within the QMS framework. • Responsible for periodic update collation conducted with the purpose of tracking revisions in device regulatory frameworks and guidelines and ensuring cross functional communication for initiating effective implementation wherever appropriate • Regulatory activities including but not limited to: contributing, executing and assisting the team with preparation of medical device CE Marking technical file, registration dossiers for emerging markets, updating device information in drug registration dossier as appropriate to reflect due to deficiency response, post approval changes, etc. • Supporting activities for ensuring GMP compliance. 2. Contribute in preparatory for liaising with – Regulatory Authorities/ Customers for International market 3. Technical Dossier Review: • Process owner and reviewer (as assigned in specific cases) of all technical documents (documents related to development, manufacturing and control of drug substance, excipients, drug product and devices). • Ensuring good documentation practice within the team. 4. Review of deviations, change control and other routine QMS governing activities: • Review and contribute to action items related to change control, deviations, CAPAs and other documents related to medical devices Show more Show less