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. This position is located in York, Pennsylvania. Offering the cultural attractions of a big city and the down-home charm of a small town, York, PA is an extraordinary place to live, work and play. York is located in south-central Pennsylvania and is within 25 miles of Gettysburg and Lancaster, 45 miles of Baltimore and Hershey, and 100 miles of Washington, DC and Philadelphia. Engrained with a rich history and heritage and becoming one of the fastest growing cities in Pennsylvania, York is a place where the past and the present comfortably coexist. **Bringing out the best in people** As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us. Working at Dentsply Sirona you are able to: **Develop faster** - with our commitment to the best professional development. **Perform better** - as part of a high-performance, empowering culture. **Shape an industry** - with a market leader that continues to drive innovation. **Make a difference** -by helping improve oral health worldwide. **Scope** Oversee all global activities related to Regulatory Affairs and Quality Assurance for the pharmaceutical products within the EDS global business unit. This includes the day-to-day interactions with the global regulatory agencies, Market Authorization Holders, and applicable departments within Dentsply Sirona. This position has primary responsibility to develop and maintain appropriate global regulatory systems, standards, and processes to establish and sustain successful relationships with global regulatory agencies. **Essential Functions** • Perform maintenance and tracking of all regulatory documentation, submissions, and KPIs. Additionally, prepare and manage applications for regulatory approval, annual and periodic reports, document control, submission compilation, and regulatory archiving. • Oversee compliance with all applicable complaint management requirements to ensure that all complaints are appropriately documented (e.g., Trackwise), reviewed for reportability in the US, Canada, and EU in a timely manner; ASR reports are generated as required, appropriately investigated, trended, and reviewed, Market Actions are appropriately assessed (HHE), initiation of applicable CAPAs, and Pharmacovigilance Related Activities. • Develop and implement systems to measure and increase quality in all areas to assure regulatory compliance. • Ensure all related quality and regulatory documentation, including external standards are appropriately managed and maintained according to established procedures. • Assist in the development of a Global Regulatory strategy aligned with business objectives. Liaise with global marketing authorization holders to manage and ensure compliance of regulations and submissions and provide regulatory strategy as required. • Work with business unit team members, contract manufacturing, and Intercompany QA/RA partners to oversee the preparation, compilation and submission of domestic and international regulatory variations and reports for new products, maintain established product lines and review modifications to established products. • Manage all activities related to the planning coordination, development, and preparation of regulatory submissions for pre and post marketed products. • Responsible for managing, coaching, and developing Quality and Regulatory associates in aspects of applicable requirements and practices. • Perform supplier or contract manufacturing audits, as needed. • All other duties as assigned. **Typical Background** **Education:** • High school diploma or GED required. • Bachelor’s degree in Quality Assurance, Regulatory Affairs, or related field preferred. • Master’s degree in Quality Assurance, Regulatory Affairs, or Business Management a plus. **Certifications/Licensing:** • Professional certification in Regulatory Affairs or Six Sigma preferred but not required. **Years and Type of Experience:** • 5 to 7 years’ experience in a Regulatory Affairs and or Quality Assurance role in life sciences preferred. • Experience in a pharmaceutical or biopharmaceutical environment preferred, including management of contract manufacturers, regulatory compliance, and submissions. **Key Required Skills, Knowledge and Capabilities:** • Good understanding of CGMP (21CFR 210 & 211), ICH guidance documents, and international regulations. • Strong computer skills with knowledge of Microsoft Office Suite (Word, Excel, Access and PowerPoint), e-mail and Internet. • Ability to effectively motivate, train, coach, mentor and provide direct leadership to direct reports. • Excellent communication skills – written and verbal. • Interpersonal skills to include customer-focused orientation with both internal and external customers. • Strong decision-making skills, ability to work independently with minimal supervision. • Comprehensive organization and analytical skills **Key Behaviors Critical for Success in this Role:** Here at Dentsply Sirona, our vision is to transform dentistry to improve oral health globally. Every day, we empower millions of customers by proudly creating innovative solutions for healthy smiles. Our Operating Principles guide our daily activities: • We approach customers as ONE company, and they are the core of everything we do. • We create innovative solutions that customers love to use. • We think and act with positive intent and the highest integrity. • We operate sustainably in everything we do. • We use our size and global breadth to our advantage. Our Core Values define who we are: • AGILE: o We innovate o We challenge ourselves constantly o We act quickly • ACCOUNTABLE: o We hold ourselves and each other accountable. • RESPECTFUL: o We listen. We foster diversity and inclusion. o We respect the communities in which we live and work. • COLLABORATIVE: o We are good partners. o We learn from each other. We are one team. We have fun. • TRUSTWORTHY: o Our customers can rely on us. o We can rely on each other. We empower our people. Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona. If you need assistance with completing the online application due to a disability, please send an accommodation request to careers@dentsplysirona.com (careers@dentsply.com) . Please be sure to include “Accommodation Request” in the subject. **For California Residents:** We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity). For additional details and questions, contact us at careers@dentsplysirona.com