연봉 Negotiable based on experience
컨설턴트 Rachel Park
채용 공고일 2019년 2월 5일 (화) 2019-02-052019-04-06 manufacturing-and-production 서울시 KR KRW 50000000 80000000 80000000 YEAR Robert Walters https://www.robertwalters.co.kr
An international medical device manufacturer is recruiting for a RA/QA Manager. In this role, you will assist the business leaders and regulatory agencies in management of product registration process and coordination of activities concerned with the submission and approval of products to government regulatory agencies.
- Spearhead all procedures of product registration and administrative tasks and including compiling registration submission, filing relevant documents, reports, etc
- Consults with APAC RA personnel to establish and prepare appropriate regulatory filings for product approvals
- Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new medical devices and regulatory support of marketed products.
- Report and provide product registration status and results to her/his director and dept head as well as business department and related parties to help their plan and business of company
- Closely monitor and communicate with regulatory agencies to Seek resolutions on issues or formal dispute that may arise and Manage related RA and QA matters
- Supervise customer complaints, FSCA, adverse event reporting, etc to comply with local regulatory requirements and procedures.
- Support RA&QA director to ensure compliance of QMS per medical device regulations and company standards. Prepare and support RA&QA Manager for internal and external audits. Support post auditing activities and CAPA follow-up & closure
- BA in science, engineering, medical or related
- 10+ years’ experience in RA & QA in the medical device industry
- Business level written and verbal proficiency in both Korean and English
About the Company:
A global technology leader in the medical industry with over two decades of experience. This company mainly produces medical devices to assist surgery with minimal invasion and is rapidly growing in the Korean market.