Job Description

Required Experience 7-10 Years

Required Skills

• Knowledge of ISO 9001:2015 & ISO 13485:2016
• Knowledge of CE marking
• Regulatory affairs for medical devices

Gained exposure in regulation of Class II device such as electrosurgical units and Class I devices such as OR lights source Coordinate with notified body for ISO 13485: 2016, CE Mark certification audits, other regulatory work Managed the existing quality systems with integral quality documents including SOPs, WRSs and DSs in Compliance with ISO 13485 and GMP requirements, while bringing fresh ideas for continuous improvement. Prepare and implement all mandatory documents as per ISO 13485 & CE standard’s requirements. Manage and contribute to the effective closure of internal/ external audit findings and customer complaints through the effective implementation of CAPA system. Coordination with all departments for their documentation & regulatory compliance requirement fulfillments. Implementation of ISO 13485 Quality Management System and maintaining related documentation for the periodic audits. Ensuring that the quality system is understood and implemented throughout the organization on all levels by concerned personnel. Preparing SOPs, WRSs and DSs for all process in the organization and oversaw its implementation Conducting internal audit. Regulatory Affairs Develop and execute regulatory plans for the Critical Care products. Ensure products comply with national and international Quality System Standards and Regulations. Advice, documentation, and co-ordinate on registration of products. Ensure appropriate submission of licenses. Coordinate for license renewals before deadlines. Negotiate with regulatory authorities for marketing authorization. Liaising with and making presentations to regulatory authorities Manage regulatory inspections. Maintain regulatory filings and compile all documentation needed for reporting. Monitor global regulatory trends and requirements. Support product owner in assembly of process/product regulatory submission and assist in follow up questions. Understanding of international regulatory requirements for medical devices. Customer complaint analysis & records for the same should be maintain for business analysis Fulfilling, document requirements for Registration of Medical Devices in various international countries. Customer comparison data should be done by D&D team Leaflet data will be provided by QA/RA. Coordination with DTP for designing leaflet should be done by marketing. Preparation of Instruction Manual for Medical Devices. Preparation of Technical File and Post Market Surveillance for Medical Devices. Educational Qualification : B Tech, BE, B Pharma, M Pharma