|[Cook Medical] RA Specialist(5-7년차/대리-과장/정규직)|
|작성자||최귀은||조회수||464||작성일||2021-05-18 오후 4:56:00|
The position reports to RA Director of Korea and primary responsibilities include, but are not limited to:
- To get MFDS approvals to facilitate and ensure smooth and timely introduction of new products according to SBU needs.
- Provide status report and submission and approval status of registration to RA Director.
- Develop the appropriate strategies and proactively take an action for post-market approval / re-evaluation / KGMP.
- Establishes and maintains reasonable and responsible regulatory climates locally through good networking (e.g. with other cross-functional/sector/category/regional/colleagues).
- Work with Cook manufacturers to provide strategy and multiple options for meeting regulatory requirements (Provide “can do” solutions, not “cannot do” roadblocks)
- Write and review Regulatory Submissions professionally.
- Train stakeholders on Korea regulatory requirements and regulation such as sales team, Cook manufacturers, etc.
- Negotiate with local authorities on behalf of Cook objectives
- Collaborate with Quality and Reimbursement team for all submissions where applicable
- Actively participate in industry activities to influence favorable regulatory policies for company interest.
- Learn the Cook Group vision and ensure regulatory compliance.
- 5-7 years of medical device RA experience (In Korean title, Daeri - Gwajang position)
- Experience in regulatory for medical device industry
- Experience in negotiating with regulatory authorities
- Experience in making submission document and getting approval
- Degree in science, engineering and law are preferred
- 5-7 year RA Working experience in foreign medical device companies
- Fluent in English, both spoken and written
- (Capability to Train overseas manufacturers, attend/lead conference calls with overseas manufacturers)
- Experience working for multi-national companies
- Interpersonal Skills and Team Player
- Organizational Skills
- Positive attitude
- ? Willingness to improve job related knowledge throughout constant self-study on local/overseas regulation and active participation to industry activities.
- Organized, good management and planning skills
- Ability to work closely with people at all levels
- Excellent communication skills
- Strategic thinker with excellent time management skills
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