Regulatory Affairs Operations Manager USA Home Office, -, US, NA
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.
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