Job Description

Responsible for Executing the deployment of innovative Regulatory strategies for New Product Introductions. Collaborating with International Regulatory team to come up with creative and Innovative strategies for Accelerated Market clearances. Lead and enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs, and other functions at all levels within the Business Unit. Responsible for building proactive, robust, strategic relationships with external stakeholders to enable Tender support and Audit support. Providing MDSAP Audit support. Responsible for efficient SAP Regulatory Controls tracking building proactive, robust communication and ensure Products are meeting the Market regulatory requirements. Responsible for providing value added Regulatory service to Philips Integrated Landscape initiatives like BlueHeart SAP MBP, Windchill, RIM (Regulatory Information Management) Creating, updating and managing Document Change Order in Documented Information Management (DIM) tool Managing and driving EUDAMED, GUDID and Country UDI submissions, Creating and uploading and correcting DTIs (Data Trade Items) in Windchill OPDM You are a part of Ultrasound Regulatory Operations team based out of Philips Innovation Campus, Bengaluru working for Philips Ultrasound LLC, USA Based organization To succeed in this role, you should have the following skills and experience Minimum of 5 years experience in Regulatory Affairs Your skills include proven experience and expertise in Global regulatory submissions, Software- IEC 62304, and Health Canada, Australia -TGA requirements, World-wide Regulatory submissions including Brazil, Russia, Singapore, Indonesia etc., Exposure to Software Regulations (SaMD/Cybersecurity/SaaS) etc., India Medical Device Regulations experience Exposure to RIMsys, Windchill etc., GUDID/EUDAMED submission experience Experience with SAP Regulatory Controls. You have a minimum of a Bachelor s Degree. Master s/MBA degree desired.