[메드트로닉코리아] Sr RA Specialist (정규직채용)

Careers that Change Lives 

Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Should you be looking for the opportunity to be on the cutting edge of medical devices regulatory affairs, apply now and we’d be happy to hear from you! 

The Sr Regulatory Affairs Specialist will be based in our Glass Tower, Seoul office. This is a unique opportunity to join the Regulatory Affairs Team to ensure the appropriate licensing, marketing, and legal compliance of a range of our medical devices to control their safety and efficacy mainly for all products. You will be an experienced Regulatory Affairs Specialist, having had min 6 year’s relevant experience preferably within the medical devices industry. It is a wonderful opportunity over time, to take your monitoring career towards your career growth in medical technology and device research.

At Medtronic, you will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. 

Together, we can transform healthcare.

A Day in the Life

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits, and inspections

• Leads or compiles all materials required in submissions, license renewal and annual registrations

• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance

• Monitors and improves tracking / control systems

• Keeps abreast of regulatory procedures and changes

• May direct interaction with regulatory agencies on defined matters

• Recommends strategies for earliest possible approvals of clinical trials applications

• Direct communication with global stakeholders

• Work in collaboration with KGMP

• Regular registration status update to global and local stakeholders

Must-Have

• Completed Bachelor's degree in any discipline 

• 6 - 8 years of experience in a regulatory affairs role in medical devices industries

• Good understanding and working knowledge of QARA Operations

• Must have effective written and verbal communication skills in both English and Korean languages 

• Excellent stakeholder relationship management

• Achievement oriented and ability to drive results with the highest quality standards

• Computer skills (excellent knowledge of MS Office products)

Nice-to-Have

• Medical devices and class IV product licensing experience is highly regarded

• Korea Good Manufacturing Practice experience is a great plus