FDA Approval Specialist/Manager

[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