SUMMARY OF POSITION:

This role is responsible for establishing, maintaining and improving the regulatory (RA) and quality (QA) systems to ensure:

·        Dentsply Sirona Korea activities meet corporation and medical device regulatory requirements in Korea. 

This is achieved by managing and working with Korea RAQA 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.

·        Create, maintain and update procedures about regulatory and quality procedures and systems. Ensure the compliance with Korea GDP (Good Distribution Practice).

·        Prepare and present budget on regulatory and quality 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 10 years medical devices regulatory and quality work experience and 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.