*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 Sa MD medical device company! Roles & Responsibilities Responsible for the global registration of the products(Sa MD) 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 Sa MD(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 → Competency-based interview → Culture-fit Interview → Onboarding After the final interview, we may proceed with reference checks if needed Work Conditions and Environment Work type: Full-time Work location : Lunit HQ(5 F, 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 new office is one minute away by foot from Gangnam Station Exit 3 making it very convenient Up to 12,000 won is covered for both lunch and dinner when working at the office Up to 300,000 won is covered upon joining to decorate your personal workspace Provide the latest computer models, such as Macs and 4 K monitors, and renew them every three years Attending seminars and purchasing books are covered Regular in-house AI and medical seminars are held Korean language education is provided for Lunitians who do not speak Korean as their first language Access high-quality AI learning resources & deep learning Dev Ops system Up to 1.2 million won worth of benefits points can be claimed annually Korean National holiday gift: Seollal and Chuseok gift/voucher Annual medical checkups and employee accident insurance are provided Financial support for employees gathering once a month is provided