*This position is open for candidates who currently reside in or are willing to relocate to Seoul, South Korea and are bi-lingual in both English and Korean*


Lunit (Volpara's parent company) 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.


The Regulatory Affairs team leads the global registrations for target countries and maintains Pre-& Post-market requirements. The team also provides regulatory insights and supports various internal & external audits under relevant Medical Device regulations.


What you will be doing:

• Registering Lunit's products in the target marketings.
• Monitoring of Pre- & Post- market requirements of target countries.
• Preparing document packages for global submissions, internal & external audits, and inspections.
• Access external communications related to regulations.
• Developing the regulatory strategy for each country and updating the strategy based on regulatory changes.

What you will bring to the role:
Required

• Minimum 3 years of relevant work experience in regulatory in medical device and/or pharmaceutical industry.
• Bi-lingual, fluent in English and Korean (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

• 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

What you will receive:

• Competitive salary based on your experience.
• 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 Dev Ops 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 employee gatherings are partially covered.

Other things to note:

• This is a full-time role based at Lunit's HQ in Seoul. If you are not currently based in Seoul, you must be willing to relocate.
• It is anticipated the successful candidate would start in around January 2025.
• Lunit is committed to providing preferential processing to those eligible for employment protection (national merits and people with disabilities) relevant to related Korean laws and regulations.