NIRAMAI Health Analytix is looking for a smart and dynamic individual for managing the quality and regulatory aspects of product development to ensure compliance and quality requirements according to various compliance requirements. Primary Roles and Responsibilities: - Development of the quality strategy for the existing and future global expansion plans - Manage and deliver QMS improvement, optimization, and maintenance projects in line with Niramai's objectives - Evaluate audit findings and nonconformance, managing the implementation of CAPAs and root cause analysis - Promoting and assisting process development and continuous improvement for all areas of Niramai - Ensure conformance to all regulatory and quality requirements applicable to Niramai - Support departmental heads in the identification and implementation of improvements in procedures and determining process performance indicators - Identifying and delivering process and system changes to improve the effectiveness and compliance of the Quality Management System - Evaluate failures; identify cause and responsibility along with initiating corrective action. - Assist in monitoring all activities to ensure regulatory adherence. - Interact with component/ accessories supplier(s) associated with supply quality - Review and approve the creation, revision, and control of quality system documents needed to ensure product quality and adherence to applicable regulations - Responsible for driving Global Product Registrations by working with applicable service providers and maintaining compliance with applicable international regulations - Responsible to identify, plan and cut out tasks and responsibilities within the QA&RA team in line with Niramai's goals - Provide feedback and mentor the QA&RA team with the quality and regulatory activities Competency Requirements for the role: - 10+ years of strong experience in Quality Assurance and Regulatory role - Graduate in any field - Good knowledge of QMS, Documents handling, and In- process quality checking with good communication with Inter departments - Familiar with and understands Quality and Regulatory standards such as CE Mark, FDA, ISO 13485, ISO 14971, MDR framework and standards, NMPA regulations - Strong communication & interpersonal skills and ability to build high- performing teams. - Must be able to handle multiple tasks, prioritize and pay close attention to details - Ability to work independently and be highly motivated in a fast- paced environment

Bangalore

Niramai - Lead - Quality Assurance & Regulatory Affairs 

Job Description for Niramai - Lead - Quality Assurance & Regulatory Affairs  in Niramai Health Analytix Pvt. Ltd. in  Bangalore for (10-15) years of experience. Apply Now!