*This position is open for candidates who reside in Korea and have a Korean proficiency appropriate for working in a Korean business
"Conquering cancer through AI"
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
🏃♀️ 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.
