담당업무

The Senior Regulatory Affairs Specialist will provide Regulatory & Quality support and direction to products from concept to launch. 
The Sr. RAQA Specialist follows the regulatory strategy for assigned corporate projects. Assists in creating, developing, and implementing global regulatory affairs procedures for marketed products and to ensure company’s regulatory compliance status and company’s GBL compliance and local regulations. 
The Senior Regulatory Affairs Specialist fulfils some of the responsibilities of the Person Responsible for Regulatory Compliance and GBL QMS compliance, in a shared capacity. 

자격요건

ㆍ학력 : 대졸이상

ㆍ경력 : 경력7년↑

? Understanding of ISO 13485 requirements and Korea medical device regulations.
 ? Ability to read and understand technical material.
 ? Excellent attention to detail ? Excellent organization skills 
? Excellent written and verbal communication skills. 
? Strong commitment of compliance with the relevant rule and procedures. 
? Computer literate, with intermediate skill in the use of Word, Excel and Outlook, and some knowledge of relational database systems, e.g. Agile Project Management system.
 ? Ability to work effectively either alone or as part of a team. Managing time effectively and completing tasks on time with general supervision.
 ? Experienced at reviewing and approving product license, GMP license, Ad-promo material and product labelling.
 ? Flexible and able to self-manage multiple priorities. 
? Able to work effectively in multinational/multicultural environments. 
? Effective communication skill in both Korean and English.


담당자 메일로 워드파일의 영문이력서를 보내주십시오.
해당 시 연락 드립니다.
drim2you@hrkimberly.co.kr