[담당업무]

-Communicate and align with marketing, sales, operations, finance and GM on the registration plan and strategy, and timely update on the status as well as the actions taken to address any delay or potential delay.
-Communicate for the documentation required and support needed.
-Review the documents received, prepare local dossiers, and submit to local health authorities
-File all the licenses/certificates and maintain and regularly update the license list and update the registration status in the company system.
-Develop and/or update the local label/IFU per the approved license.
-Lead the company certification as well as inspection if it’s required for the certification.
-Review and approve the promotion materials
-Review and evaluate the regulatory Changes/Trends, lead the actions to address the changes and minimization the business impact.
-Escalate any major/critical and urgent regulatory compliance issue in timely manner, whenever applicable.
-Manage reimbursement project
-Work with QA counterpart in manufacturing site to maintain and improve Quality Management System (QMS) in the company, to ensure the QMS is running effectively and
compliance to Korea requirement, and the local regulatory requirements.,
-Working together with function leaders, set up training matrix for all the quality related training, and review it at least once a year
-Participate in the internal audit and external audit, including the audit/inspection by regulatory authority and notify body.
-In house test when the company product import to local office.
-Timely coordinate the disposition of non-conforming products and make the decision on the product return if necessary.
-Manage CAPA

[자격요건]

경력사항: 경력(5년 이상 )
학력사항: 대학교(4년)졸업
기타:

•Minimum 5~10 years experience in RA
•RA&QA experience as standalone contributor(with no supervision by RAQA director) in Korean manufacture
•Must be excellent in project management, risk management and effective and clear communication
•Self-starter and willingness to take ownership on extensive RA&QA matters with proactive manners and continuously learning mindset
•Working level of English; frequent verbal and written English communication with various partners in the US, Europe, and APAC
•To keep up the latest guideline an market practice through continuous external trainings

[우대사항]

외국어: 영어 회화가능,독해가능,작문가능, TOEIC 800점