Regulatory Affairs Specialist 2

The Regulatory Affairs Specialist II plays a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) products are safe, effective, and compliant with global regulatory rules and standards. This role will provide cross-team support on key compliance and regulatory activities such as SOPs (Standard Operation Procedures) tracking audits and audit readiness.
**Your responsibilities:**
+ Manage regulatory master data across PLM, RIM, and ERP platforms.
+ Partner with internal teams and external stakeholders to streamline processes and solve challenges.
+ Support establishment registration, product listings, and UDI/GTIN activities, ensuring smooth regulatory filings and licenses.
+ Prepare and coordinate regulatory submissions for product licensing, driving accuracy and efficiency.
+ Review product labeling and marketing materials to ensure compliance with global standards.
+ Stay ahead of regulatory changes and contribute to continuous process improvement...