Regional RA

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:

• Manage the registration and approval processes for medical devices in accordance with the requirements of domestic, European, and other international markets
• Develop and implement regulatory strategies for new product development and modifications to existing products
• Prepare and submit regulatory documentation for both domestic and international submissions
• Handle communications with regulatory authorities, including responding to inquiries and maintaining relationships with domestic and international consultants
• Collaborate with cross-functional teams to support all aspects of product development, including research, development, clinical trials, and approvals
• Monitor compliance with regulatory standards and guidelines across various countries
• Maintain documentation and records for internal and external audit preparations
• Support post-market surveillance activities following product launch

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
• Strong understanding of KFDA, EU MDR, ISO 13485, and other regulatory requirements

Preferred:

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

Competencies:

• Strong analytical and problem-solving skills
• Excellent communication and collaboration abilities
• Ability to manage multiple tasks in a fast-paced environment
• Attention to detail and strong documentation skills

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