Lunit, a portmanteau of ‘Learning unit,’ is a medical AI software company devoted to providing AI-powered total cancer care. Our AI solutions help discover cancer and predict cancer treatment outcomes, achieving timely and individually-tailored cancer treatment.

🗨️ About the team

Lunit Regulatory Affairs team is leading the global registrations for target countries and maintains Pre-& Post-market requirements from the target countries. Also, provides proper regulatory insights and supports various internal & external audits under the Medical Device regulations.

🗨️ About the position

We’re hiring a new RA specialist who would be willing to join this attractive(!) RA team of Lunit. Looking forward to being together with us on the journey as a first mover in the AI-based SaMD medical device company!

🚩 Roles & Responsibilities

  • Responsible for the global registration of the products(SaMD) of Lunit.
  • Responsible for the regulation monitoring of Pre- & Post- market requirements of whole target countries.
  • Preparation of document packages for global submissions, internal & external audits, and inspections.
  • Access external communications related to regulations.
  • Develop the appropriate country regulatory strategy and update
    strategy based on regulatory changes under the medical device regulation.

Requirements

🎯 Qualifications

  • Minimum 3 years of relevant work experience in regulatory in medical device and/or pharmaceutical industry.
  • Fluent in English(both spoken and written)
  • Pre-market submission experience for global regulatory bodies.
  • Manage changes for labeling, manufacturing, and marketing for regulatory compliance.
  • Well-structured documentation skills(Submission dossiers, TD)

🏅 Preferred Experiences

  • Experience in SaMD(Software as Medical Device)
  • US FDA and/or Japan PMDA submission experience
  • Experience in AI-based product
  • Strategic thinking and logical approach 

📝How to Apply

  • CV (resume, free format)

🏃‍♀️ Hiring Process

  • Document Screening → Introductory Interview → Competency-based Interview → Culture-fit Interview → Onboarding
    • After the final interview, we may proceed with reference checks if needed
    • The expected start date is in January 2025.

🤝 Work Conditions and Environment

  • Work type: Full-time
  • Work location : Lunit HQ(5F, 374, Gangnam-daero, Gangnam-gu, Seoul)
  • Salary: After negotiation

🎸 ETC

  • If you misrepresent your experience or education or provide false or fraudulent information in or with your application, it may be grounds for cancellation of the employment.
  • Lunit is committed in providing the preferential processing to those eligible for employment protection (national merits and people with disabilities) relevant to related laws and regulations.

Benefits

🌻 Benefits & Perk

  • The office is at a very convenient location, just a minute away from Gangnam Station Exit 3.
  • Meal Allowance is provided (up to 12,000 KRW per meal) when working at the office.
  • Up to 300,000 KRW is covered upon joining to decorate your personal workspace.
  • Latest computer models, such as Macs and 4K monitors are provided and can be renewed every three years.
  • Seminar registration fees and book purchases are covered.
  • Regular in-house AI and medical seminars are held.
  • In-house English lessons (aka Luniversal) is provided for English development.
  • Access to high-quality AI learning resources & deep learning DevOps system.
  • Up to 1.2 million KRW worth of benefits points can be claimed annually.
  • Holiday Allowances are provided in the form of gifts or vouchers for Korean National holidays, Seollal and Chuseok.
  • Congratulatory and Condolence allowances, along with paid time off are provided.
  • Annual medical checkups and employee accident insurance are provided.
  • Expenses for monthly employees gatherings are partially covered.