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.

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.

덴츠플라이시로나에서 일하면 다음과 같은 것들을 할 수 있습니다:
더 빠른 성장 - 최고의 전문성 개발을 위한 노력으로 빠르게 성장할 수 있습니다.
더 나은 성과 달성 - 역량을 강화하는 고성능과 문화의 일원으로 일할 수 있습니다.
산업 형성 - 혁신을 지속적으로 주도하는 시장 리더와 함께 산업을 형성합니다.
변화 만들기 - 전 세계 구강 건강 개선에 기여합니다.

덴츠플라이시로나코리아(유)는 1998년에 설립된 회사로 자본금 11억 1,888만원, 매출액 500억, 사원수 100명 규모의 외국계(외국 투자기업)입니다. 서울 송파구 법원로 135(문정동, 소노타워)에 위치하고 있으며, 치과 장비 및 치과용 기자재(임플란트 제품) 도소매, 무역/판촉, 경영자문 사업을 하고 있습니다.

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

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.

지원 방법

1. 이메일 지원 (자유 양식)
2. 이력서는 지원하는 포지션을 기재하여 `국문/영문 이력서를 하나의 파일로 접수` 부탁 드립니다.
3. 이력서 상에 직전연봉, 희망연봉 기재 필수

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.