מציאת משרת הייטק בחברות הטובות ביותר מעולם לא הייתה קלה יותר
Philips Regulatory Operations Specialist India, Karnataka, Bengaluru 961744945
Regulatory Affairs Specialist – Ultrasound, Regulatory Operations will have an exciting opportunity to lead the Regulatory Affairs Strategy and help business with World-wide product registration, actively providing value-added regulatory affairs service and deliverables for new product introductions and product changes across the globe. Leading and supporting SAP Regulatory controls to ensure products are safe, effective, and meeting the target market Regulatory requirements.
You are responsible for
Executing thedeploymentof 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
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.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .
Our hybrid working model is defined in 3 ways:
משרות נוספות שיכולות לעניין אותך
