Responsible for managing and leading the Dentsply Sirona team supporting Global Unique Device Identification (UDI), Food & Drug Administration (FDA) Establishment Registrations and Device Listings
Responsible for overseeing the centralized team that manager US State Licenses and required regulatory databases
Responsible for providing guidance for updates to FURLS to maintain accuracy of FDA Establishment Registrations and Device Listing, including submission of annual re-registration
Provides regulatory guidance and support to cross-functional teams for global UDIs
Manage US State licenses for all medical device activities
Identify regulations or requirements that are new that could impact Dentsply Sirona Quality Management Systems or our products and communicate to sites for gap assessment and implementation
Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships
Manage day-to-day activities for regulatory operations team
Complies with company and departmental policies and administrative requirements
Performs other duties as assigned or as needed

5(+) years of experience in regulatory affairs, preferably in the medical device industry
Experience with leading regulatory operations for medical devices
Knowledge of FDA regulations and international standards (e.g., ISO 13485)

Regulatory Affairs Operations Manager

Key skills