Regulatory Affairs Operations Manager (USA Home Office, --, US, NA)
DSDentsply Sirona — United States🇺🇸
Requistion ID: 83321
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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. Dentsply Sirona’s headquarter is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.dentsplysirona.comfor more information about Dentsply Sirona and its products. |
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.
Equal Opportunity Employer: Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law. Eligibility: All successful applicants must be eligible to work in the country the position is based. Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to [email protected]. Agencies: Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms. Notice on Fraudulent Job Offers: Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: careers.dentsplysirona.com.
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Originally posted on Himalayas
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