글로벌 의료기기 회사의 포지션입니다. 궁금하신 내용은 언제든지 010-8763-1936으로 전화주시기 바랍니다. 

업무내용

1) Registration Activity

1. - Prepares, compiles, and submits regulatory documents for the registration of current and new products in assigned markets. 
2. - Maintains submission documents, and agile databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information. 
3. - Monitors pending submissions to ensure timely approvals. Communicates to management any identified delays that may impact business expectations. 
4. - Monitors approved registrations in respect to expiry and ensures management is aware of action required to renew in a timely manner to ensure no disruption in product distribution. 
5. - Interacts with Regulatory Affairs personnel at regulatory agencies, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate to avoid any potential delays in approval.

2) Monitoring Registration Requirements within Region

1. - Maintains up-to-date knowledge of regulations, guidelines, and advisory documents required for marketing products in Korea. 
2. - Communicates applicable regulatory requirements to management and business partners. 
3. - Analyses impact and communicates to Sr. RAQA manager changes in regulations or requirements that have been identified. 

3) Compilation of Technical Documentation

1. - Authors approval documents and compiles Notified Body submissions in line with Technical documentation procedures for Korea regulations. 
2. - Supports RAQA Management with Notified Body requests for information.  

4) Support to Processes 

1. - Represents the perspective of regulatory affairs to the company. 
2. - Interprets general business objectives and effectively present information to manager and regions. 
3. - Reviews and approves product labelling. 
4. - Initiates IFUs and other required product labelling in line with relevant Korea MD regulation requirements. 
5. - Supports “Own Brand” and “Private label “ customers and liaises as necessary 
6. - Provides input to Regulatory Affairs Impact Documents (RAIDS) from Korea perspective. 
7. - Act as a resource to the regions on quality issues and propose changes to minimize risks and enhance quality, reliability, safety and productivity. 
8. - Act as spokesperson, when appropriate, regarding CooperVision practices, public policy, business interests; arrange for technical explanations from internal or external experts. 
9. - Support RAQA compliance activities as necessary in assigned Korea

Qualifications 

1. - Understanding of ISO 13485 requirements and Korea medical device regulations. 
2. - Effective communication skill in both Korean and English.
3. - +6 years of medical device regulatory experience.  
4. - Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
5. - Network-building and contact experience as related in Medical Device law. 
6. - Preferred internal and external audit (e.g. GMP) experiences.