Regulatory Affairs Specialist
연봉 Negotiable based on experience
컨설턴트 Jessie Jin
채용 공고일 2019년 1월 22일 (화) 2019-01-222019-03-23 medical-and-nursing Seoul KR KRW 70000000 80000000 80000000 YEAR Robert Walters https://www.robertwalters.co.kr
A large medical equipment company is searching for a Regulatory Affair Specialist. This position will have a variety of responsibilities, including new product registrations, licence modifications, impact assessments, etc.
- Execute regulatory affairs strategy, dossier creation and review, communication with manufacturers, etc.
- Manage product and license changes according to relevant changes in regulations
- Produce regulatory affairs impact assessments
- Conduct regulatory affairs updates
- Carry out new site registration and renewal management, documents submission, on-site audits, etc.
- Support medical device reimbursement submissions
- 5+ years of experience in regulatory affairs
- Extensive knowledge of Korea laws and regulations for medical devices
- Fluent level English
About the Company:
A medical equipment company that specializes in products used in a number of cardiovascular treatments, the organization is the leader in its field. With unique technology that is relied upon by medical professionals and institutions worldwide, this company continues to have a commanding market position.