Regulatory Affairs Operations Manager

Dentsply Sirona, Inc • USA Home Office, --

2d • Hybrid

About The Position

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dental care. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

Requirements

• 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)
• Strong results orientation and analytical skills

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager