Senior Regulatory Affairs Specialist

**Senior Regulatory Affairs Specialist, Ultrasound**
The Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams and authorities to secure timely product clearances. Responsibilities include coordinating and preparing regulatory submission documents for agencies such as the FDA, Health Canada, EU Competent Authorities, NMPA, and ANVISA, and offering strategic guidance on clinical studies and evaluations.
**Your role:**
+ Act as an ambassador of Philips values and ensure compliance with all relevant business processes and regulatory procedures.
+ Serve as the Regulatory Affairs representative for BG Ultrasound, providing guidance on regulatory issues related to product development, labeling, and marketing strategies.
+ Coordinate and prepare documentation for regulatory submissions—such as Product Reports, Technical Files, Declarations of Conformity, and Medical Device Licenses—for various global markets.
+ Support cross-functional teams ...