Regulatory Affairs Operations Manager

POSITION SUMMARY:

The Regulatory Affairs Operations manager is responsible for managing and leading the Dentsply Sirona team supporting Global Unique Device Identification (UDI), Food & Drug Administration (FDA) Establishment Registrations and Device Listings. The role is also responsible for overseeing the centralized team that manager US State Licenses and required regulatory databases.

PRIMARY RESPONSIBILITIES:

• 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

REQUIRED KNOWLEDGE, SKILLS, and ABILITIES:

• 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)

KEY LEADERSHIP BEHAVIORS:

• Actively articulates and promotes Dentsply Sirona’s vision and direction
• Advocates on behalf of the customer
• Values driven with an insistence on excellence
• Promotes high performance, innovation, and continual improvement
• Consistently meets Company standards, ethics, and compliance requirements.
• Strong results orientation and analytical skills

 EDUCATIONAL QUALIFICATIONS:

• Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or related discipline

ENVIRONMENTAL REQUIREMENTS:

• Primarily an office environment; must be able to use all office equipment (PC, internet, phone, fax, copier, etc.).
• Limited temperature fluctuations.
• If working remotely, must have access to a dedicated remote working space.