Develop Korea regulatory strategies and lead MFDS dossier preparation and submissions
Prepare regulatory applications on time per committed product launch timelines
Monitor Korean regulations and serve as primary MFDS communication contact
What they want
Bachelor's degree in science plus two years Korean medical device IVD RA experience
Expert knowledge of MFDS medical device IVD and digital health regulations
Strong strategic thinking problem-solving skills and collaborative cross-functional mindset
Advertisement
Nice to have
IVD or SaMD registration experience and clinical performance study background preferred
Seoulstart's read
Visa tier (likely)
E-7 specialty / professional (likely)
Korean language
Business-level Korean required
English friendliness
Medium: English JD, mixed-language workplace
Context
Roche Diagnostics Korea affiliate; expect MFDS-facing work and mandatory current and desired salary on your resume.
This is Seoulstart's analysis of the public job description, not the employer's stated policy. Verify visa sponsorship, language requirements, and remote allowances directly with the recruiter.