RA Specialist

About us:

Mediwhale is a pioneering AI healthcare startup focusing on predicting cardiovascular, renal, and metabolic disease (CVRM) risks using retinal biomarkers. The eye is the only organ where blood vessels are directly visible without invasive procedures, which is our key to unlocking unprecedented insights into human health.

At Mediwhale, the Regulatory Affairs Specialist collaborates with health authorities to establish and manage device registrations and regulatory strategies, ensuring regulatory approval and ongoing compliance for medical devices both domestically and internationally. This role is crucial in supporting essential regulatory processes for the launch of new products and the quality assurance of existing products.

Responsibilities:

• Domestic Medical Device Licensing & Regulatory Affairs (MFDS)
  • Regulatory Leadership (MFDS): Oversee all Ministry of Food and Drug Safety (MFDS) licensing activities, including managing medical device certifications and permits.
  • Strategic Compliance: Proactively monitor domestic regulatory shifts, such as the Act on Digital Medical Products, and establish forward-looking licensing strategies.
  • Lifecycle Management: Manage version control and synchronization for both new and existing licensed products to ensure continuous compliance.
• New Health Technology Assessment & Market Access (NECA/HIRA)
  • Health Technology Management (NECA): Manage New Health Technology Assessment (nHTA) processes and navigate (deferred) new health technology pathways.
  • Reporting & Compliance: Lead the preparation and submission of monthly performance reports in accordance with the Management Guidelines for Innovative Medical Technology.
  • Market Access Strategy: Formulate and execute strategies for Health Insurance Review and Assessment Service (HIRA) reimbursement/non-reimbursement applications (Phase II).
  • Pathway Optimization: Explore and utilize accelerated market entry pathways, including Integrated Review for Innovative Medical Devices, the Immediate Entry System, and Pre-Certification of Competency (PCCP).

Benefits:

• Flexible working conditions including work-from-home (2 days per week)
  • Remote work policies may change based on company circumstances or policies 
• Company-supported daily lunch and snacks
• Annual comprehensive health check-up
• Additional leaves including vaccine leave, birthday leave, and condolence leave, in addition to statutory annual leave
• Support for work-related books and job-related training

Application Process:

• Process: Document screening – 1st interview – 2nd interview – Final Acceptance
  • Tasks may be assigned according to the role, and the interview process may be subject to change.
• Application documents: Free format (including resume)
  • Please highlight your motivation for applying to Mediwhale, your interest in the position, and your strengths related to the job
  • Please submit one copy of your resume in both Korean and English.
• Interviews: Each interview is expected to take approximately 30 to 50 minutes