Senior Specialist I - RA

Responsible for leading the development/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.

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

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.