Opportunity for one of the leading shared service setup in Pune. Responsibilities: - Manage Regulatory/Quality Affairs &amp; BES team at Company India while supporting European, ANZ &amp; International business operations. - Manage preparation of regulatory submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510 (K) Notification) &amp; to European notified body. - Maintain the QMS and supporting procedures to adhere for ISO 13485, as well as FDA, European (CE Mark) requirements. - Review and approve Pre-launch product submissions (technical files) to ensure compliance with internal company requirements and compliance with regulatory requirements - Manage prioritization of technical file within the team &amp; ensure the delivery of files within the targeted timelines. - Responsible for improving the turnaround time &amp; quality of Technical files. - Ensure adherence of company core values within team members. - Ensure continuous engagement with leadership to stay aligned with the vision &amp; growth plans. - Collaborate with multiple stakeholders across (US, Europe and other regions) geographies for successful engagement. - Prepare, implement &amp; manage mechanism to solicit feedback from strategic partners for team's collaboration and alignment with expectations. - Establish key performance indicators, monitor ongoing performance, and improve performance in line with established goals. - Identify areas for process improvement with the team with the domestic and overseas support groups while enhancing productivity metrics. - Drive the maintenance of Product Information Management system as well as CSR and QA/RA information database. - Define data warehouse requirements and participate in solution design with relevant stakeholders - Develop and implement databases, data collection systems, data analytics and other strategies that optimize statistical efficiency and quality. - Identify, analyzing the data/reports from different perspective while developing the analytical tools for performance reports, alerts, events for business users. Work Experience: - Prior experience of working in Captive/GIC/Shared services (Medical device industry) will be preferred. - 8 To 10 years of total experience out of which minimum 2 years of Managerial experience in managing a large size RA/QA teams &amp; sales support/customer service teams. Should have managed more than 2 team leads. - Previous experience of building teams around Q/RA &amp; Product Support operations is a must. - Strong experience of conducing - Performance reviews- for at least 2 formal cycles. - Strong experience of managing multiple stakeholders across diverse geographies Shefali

Pune

Regulatory Affairs Manager - Shared Services 

Regulatory Affairs Manager - Shared Services  ,Job Description for Regulatory Affairs Manager - Shared Services  in Kelly Services in  Pune for (8-15) years of experience. Apply Now!

Job Description for Regulatory Affairs Manager - Shared Services  in Kelly Services in  Pune for (8-15) years of experience. Apply Now!