RA&QA 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:

• Develop and execute regulatory strategies for new product development and existing product modifications
• Manage medical device approval and registration tasks
• Manage and collaborate with domestic/international consultants
• Collaborate and coordinate with various internal stakeholders including product development and research organizations
• Manage the entire process of Quality Management System (QMS) from development to implementation, maintenance, and improvement.
• Lead the entire process from planning and implementing process monitoring and internal quality audits to sharing results.
• Take responsibility for overall preparation to external quality audits.
• Operate PMS, risk management, and CAPA systems.
• Continuously monitor changes in domestic and international regulatory environments

Qualifications:

• Bachelor’s degree or higher in Pharmacy, Life Sciences, Engineering, or Computer Science
• Minimum of 3 years of experience in regulatory affairs within the medical device or pharmaceutical industry, both domestically and internationally
• In-depth understanding of KFDA, EU MDR, ISO 13485, US FDA guidance, and other regulatory requirements

Preferred:

• Experience in developing regulatory strategies and project management
• Experience with MDR, FDA regulations is preferred

Competencies:

• Takes initiative and works proactively beyond defined role boundaries
• Possesses strong persuasive communication skills and ability to gain buy-in from others
• Understanding of software development processes
• Strategic thinking based on business mindset
• Document writing and comprehension skills in both Korean and English
• Development of regulatory strategy considering the entire product lifecycle
• Analyzing and problem-solving skills
• Clear communication and collaboration
• To build evidence-based logic through scientific thinking
• Adjusting priorities and effectively managing multiple tasks in a rapidly changing environment
• Ability to thoroughly review and document details
• Compliance and ethical awareness

Benefits:

• Flexible working conditions including work-from-home (2 days per week) 
• 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