Philips Senior Specialist - RA 

India, Karnataka 

196825498

Senior Specialist I - RAJob Description

Senior Specialist I - RA

Regulatory Affairs Manager – 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

• leading thedevelopment/deploymentof innovative Regulatory strategies for New Product Introductions. Collaborating with International Regulatory team to come up with creative and Innovative strategies for Accelerated Market clearances.

• Leading and driving Health Canada submissions, and updating Australia Essential Principle Checklist and DoCs.

• 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

To succeed in this role, you should have the following skills and experience

• Minimum of 8 - 12 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.

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Our hybrid working model is defined in 3 ways:

The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.