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Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history 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 dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.
Regulatory Operations Manager
Location
United States
Posted
48 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Regulatory Operations Manager
Dentsply Sirona, Inc
Role Description 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 manages 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. Qualifications - 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). Requirements - 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.
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