연봉 Negotiable based on experience
컨설턴트 Rachel Park
채용 공고일 2019년 3월 8일 (금) 2019-03-082019-05-07 medical-and-nursing Seoul KR KRW 60000000 70000000 70000000 YEAR Robert Walters https://www.robertwalters.co.kr
An American medical device company is in need of a RA/QA Manager. The candidate who enters this role will be responsible for licence approvals, medical device reimbursements, quality compliance systems, etc.
- Work with HQ to submit and maintain product license approvals and notification, quality system certification, adverse events reporting, etc.
- Prepare submissions for medical device reimbursement
- Support development, implementation, and maintenance of quality system compliance programs and procedures
- Serve as the local representative the company in Korea for regulatory agencies
- Cooperate with HQ to integrate local requirements into the company’s quality system
- 5+ years of experience in the medical device industry, in a regulatory affairs or quality system related role
- 1+ years of reimbursement experience in healthcare industry is a plus
- Detailed understanding of KGMP, Korean regulations, and experience with preparing submissions
- Experience in customs clearance, labelling, inspection, and distribution processes and procedures
- Great project management; client relations skills
- Medical device registration experience in Korea
About the Company:
Headquartered in America, this medical device company intends to help provide high-quality and affordable healthcare across the globe.