Regulatory Affairs Manager

Requistion ID : 84261 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 for more information about Dentsply Sirona and its products. SUMMARY OF POSITION: This role is responsible for establishing, maintaining and improving the regulatory (RA) to ensure: Dentsply Sirona Korea activities meet corporation and medical device regulatory requirements in Korea. Up to 10% oversight on QA activities This is achieved by managing and working with Korea RA personnel. DUTIES & RESPONSIBILITIES: Manage and coordinate registrations of products to ensure maintenance of existing registrations and timely registrations of new products. Timely update registration status and data to related Product Groups and Functions, and Management Team. Establish and communicate key registrations’ pre-submission strategies, potential regulatory pathways or clarification and follow-up of submissions under review. Maintain regulatory intelligence of existing and changing regulatory affairs. Assess changes in regulatory environment and potential impacts on registrations and operations and provide concise regulatory scenarios for management discussion and decision. Develop and maintain effective professional relationships with the regulatory authorities, legislators, trade association, and Key Opinion Leaders to ensure smooth and efficient registration processes and influence for positive change of regulatory environment. Manage (provide and review contents) Korean labelling (labels and IFUs/Manuals, UDI, Symbols) compliant with regulatory requirements. Prepare and present budget on regulatory activities. Monitor the expense compliant with internal policies and external rules and policies. Have good knowledge of Dentsply Sirona products and systems. KNOWLEDGE, SKILLS & EXPERIENCE: Education Bachelor’s degree or above. Scientific, engineering, healthcare preferred. Experience Minimum 8-10 years medical devices regulatory and quality work experience and 3-5 years team management experience. Experience working with cross cultural groups preferred. Specific Knowledge /skills Energetic with self-initiative. Excellent verbal and written communication skills in English. Strong interpersonal and influencing skills. Project management skills. Attention to details. Able to work under pressure and meet tight deadlines. Owner of logical thinking and healthy judgment, and open communication attitude to be ready to listen to what others say and to let the stakeholders understand on the regulatory system changes. COMPETENCIES: Teamwork : Empowers self and others through effective and collaborative relationships that accomplish organizational objectives. Creates strong morale, spirit and a feeling of belonging in his/her team and shares wins and successes. Brings the right colleagues together to address business/customer challenges and opportunities. Recognizes that leveraging each team member’s unique background and perspective is critical to achieving team goals. Strategic Thinking : Accurately anticipates future consequences, trends and relationships to create appropriate strategies and plans. Formulates a clear strategy and defines steps that will clearly accelerate the organization towards its strategic goals. Talent Management : Acts as a development-oriented leader by assigning challenging tasks and responsibilities that stretch the employee beyond his/her comfort zone. Demonstrates success in recruiting, assessing, coaching, training, developing, and retaining talent to meet current and future business needs and ensure a strong talent pipeline. Create a climate in which people want to do their best by inviting input from each person and sharing ownership and visibility. Empowers others by pushing tasks and decisions down. Problem Solving : Leads team in the use of problem-solving tools and processes to solve complex problems. Builds problem solving skills and encourage directs to come up with own answers. Uses logic and methods to solve difficult problems with effective solutions. Probes all relevant sources and analyses for finding solutions. Drive for Results : Motivates and encourages people to deliver outstanding and sustainable results that support the business strategy. Solves complex problems, anticipates and overcomes roadblocks and set the course and pace for action. Drives business results in own function and encourages other functions to achieve results. Accountability : Follows through on commitments and makes sure others to do the same. Creates a culture of ownership and accountability in the team and allows people to be responsible for their work and addresses gaps quickly. Establishes clear responsibilities and processes for monitoring work and measuring results. Integrity : Creates an environment where promises and confidences are kept and mistakes are admitted. Practices what he/she preaches. Continues to hold steady to our values through crises. Addresses potential ethical concerns and escalates to the right party when necessary. Customer Focus : Encourages the team to understand and represents the customer’s viewpoint to build long-term trust. Collaborates within and outside the business to gather information that is used to shape products and services. Innovation and Creativity : Encourages the team to discover novel ideas and implement innovative solutions for growth. Models how team members should take calculated risks to drive innovation. Can effectively facilitate and manage the creative process of others. Inspires or champions ideas that have true business impact. Leading Change : Anticipates change and demonstrates credibility to inspire and empower others to manage through the change and their individual transition. Plans and communicates the change effectively and strategically to relevant internal and external stakeholders. Leads and manages change without having the total picture and role models expected change and transitional behaviours. Anticipates risk and uncertainty and establishes a mitigation plan. 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 . 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: .