[Company / Industry] Digital Therapeutics / Medical Device
[Position] FDA Approval Specialist or Manager depending on qualifications
[Function] Regulatory Affairs
[Reporting Line] RA/QA Manager
[Employment Type] Permanent
[Compensation] TBD
[Location] Seoul, Korea
[Consultant in charge] Simon S. Kim
COMPANY DESCRIPTION:
Korean Startup (Completed Series A funding), leading digital therapeutics
JOB DESCRIPTION:
Responsible for establishing FDA approval strategy, planning and execution for company products
Responsible for relevant regulatory documentation, submission and follow up
Be the point of contact of the Company in new approvals, renewals and relevant project management
Support RA/QA Team in R&D projects and Technology licensing in/Out
JOB REQUIREMENTS
3+ years of relevant work experience
FDA approval experience
Fluent in English/Native Korean
Prefer candiates with regulatory affairs experience
Prefer candiates with relevant license (i.e. medical device RA experts)
Prefer candidates with experience in R&D planning and participation in goverment projects
Prefer candidates with experience in ISO/GMP/FDA/CE approval process
If you are interested, please contact simon.kim@rp4rp.com +82-10-4118-2178