A qualified professional with 19 years of experience in medical devices Quality, Regulatory and Safety standards for the global market compliance. Collaborate with the R&D to facilitate the successful execution and compliance of the New Product Development Process. Exposure to Project Management, People Management, Verification & Validation, Sustenance Engineering, Obsolescence management, Vendor Management, Supplier Quality. New Product Development, Sustenance Engineering & Obsolesce Management:• Responsible for end-to-end execution and delivery of NPD projects which involve Requirement analysis, Design, Development, Integration, V&V, Quality. Regulatory, Product compliance.• Conducting and completing phase gate deliverables PDR, CDR, FDR and SA for NPD process and Starting and Closing deliverables for bug fix maintenance projects. • Scheduling the cross functional team calls weekly to monitor the progress of the project. • Responsible for conducting and documenting the CCBs and updated in Azure DevOps for the bugs raised.• Point of contact for PMO for India R&D center.• Responsible for acting as independent reviewer for other PMs projects delivered throughout Global.• Hands on experience on Agile PLM management tool to release all controlled versions.• Updating and maintaining the design and development planning documents i.e PRD, MRD, HWRS and SWRS in Telelogic DOORS 9.6.• Scheduling the weekly updates and bi-weekly dashboard updates with the senior management. Participating in the portfolio updates with presales team.• Lead product Risk management process as per EN ISO 14971:2019.• Supporting and participating in internal and external audits.Project Management:• Good experience project monitoring, preparing and reviewing of project estimation, proposal and SOW. • Good exposure in preparing the project schedules and deliverables plan and resource loading details. Motivating the team throughout the project lifecycle.• Ensuring proper communication & stakeholder management throughout the project lifecycle. • Ensuring customer satisfaction. People Management:• Responsible for hiring and training the new employees• Leading the team as a people manager, motivating the team and ensuring defined performance outcomes• Ensure proper guidance and direction in problem solving.• Providing seamless communication to all project team members in regard of project related information • Provide opportunities to project team members for professional development and growth.• Conducting the daily standup calls to monitor the team progress.
Listed skills include Regulatory Support Specialist For Ivd Medical Products, Ce Compliance Professional For Ivd Medical Devices, Strong Iec Standars Like Iec 61326, and 2016 By Sgs.
