Career Opportunities: Regulatory Affairs Operations Manager (83321)

This a Full Remote job, the offer is available from: reputed company America, reputed company Carolina (USA) Requistion ID: 83321 reputed company 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. reputed company 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. reputed company’s products reputed company innovative, high-quality, and effective solutions to advance patient care and deliver reputed company and safer dental care. reputed company’s headquarter is located in Charlotte, reputed company Carolina. The company’s shares are listed in the United States on reputed company under the symbol XRAY. Visit www.dentsplysirona.com for more information about reputed company and its products. POSITION SUMMARY: The Regulatory Affairs Operations manager is responsible for managing and leading the reputed company 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 reputed company medical device activities
• Identify regulations or requirements that are new that could impact reputed company Quality Management Systems or our products and communicate to sites for gap assessment and implementation
• Fosters professional interactions with reputed company 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 reputed company’s reputed company and direction
• Advocates on behalf of the customer
• Values driven with an insistence on reputed company
• 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 reputed company discipline

ENVIRONMENTAL REQUIREMENTS:

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

Equal Opportunity Employer: reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will be considered without unlawful discrimination or regard for race, reputed company, religion, sex, sexual orientation, sexual or gender identity, national or ethnic reputed company, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law. Eligibility: reputed company 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 reputed company 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 reputed company parties that pretend to represent reputed company offering unauthorized employment opportunities. If you think a fraudulent reputed company is offering you a job, please have a look at the following information: careers.dentsplysirona.com. This offer from "reputed company" has been enriched by reputed company.com and got a 83% reputed company score. Apply tot his job Apply To this Job