Regulatory Affairs Specialist

About This Role

This role focuses on ensuring the timely registration and maintenance of dental product licenses, while also ensuring compliance with regulatory and corporate requirements. It suits a specialist who can manage multiple tasks in a fast-moving environment and support internal and external audits.

Responsibilities

• Account for assigned new registration and maintenance projects and updates of existing product licenses
• Anticipate regulatory environmental changes and take appropriate actions to cope with the situation
• Ensure all regulatory compliance activities and fulfill responsibilities to secure business continuity, including supporting KGMP certificates, labeling, approval variation, annual reporting, and product renewal, in accordance with country and global company regulatory requirements
• Comply with all legal, regulatory, and ethical business requirements while executing the assigned roles and responsibilities, as defined in the local regulations and Corporate procedures
• Develop and lead local language labeling and promotional material review
• Support internal tasks assigned by the line manager
• Actively participate in industry meetings and MFDS explanatory conferences, share the information from these meetings with the team and other departments
• Have experience with UDI (unique device identifier), UDI database, and in-depth knowledge of MFDS requirements

Requirements

• University/Bachelor’s Degree and Major in science or engineering preferred
• More than 3 years’ experience in regulatory affairs of medical device
• Specialized knowledge of regulatory activities
• Fluent in English
• Ability to manage multiple and varied tasks in a fast-moving environment
• Strong sense of responsibility on meeting due/target
• Good interpersonal skills and proven ability to contribute to a team environment
• No reason for disqualification for oversea travels

Nice to have:

• Experience with KGMP is favored

About the Company

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. The 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. Its products provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dental care. Dentsply Sirona's shares are listed in the United States on NASDAQ under the symbol XRAY.