US 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 the FDA and other relevant regulatory authorities to establish and manage device registrations and regulatory strategies, ensuring the regulatory approval and ongoing compliance of medical devices in the U.S. market. This role is critical in supporting essential regulatory processes for the launch of new products and maintaining the quality assurance of existing products.

Responsibilities:

• Manage the registration and approval processes for medical devices in accordance with the requirements of the FDA and other regulatory bodies
• Develop and implement regulatory strategies for new product development and modifications to existing products
• Prepare and submit regulatory documentation, including 510(k), De Novo, and other submissions
• Handle communications with regulatory authorities, including responding to inquiries and managing 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, including those related to device approval
• Maintain documentation and records for internal and external audit preparations
• Support post-market surveillance activities after 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
• Deep understanding of FDA processes and requirements, as well as other regulatory agencies
• Experience preparing regulatory submissions for US, EU, and other international markets

Preferred:

• Experience with US regulatory submissions such as 510(k), PMA, and IDE, and direct communication with the FDA
• International regulatory experience (e.g., CE Mark, ISO certifications)
• Experience with regulatory affairs related to Software as a Medical Device (SaMD)
• Proficiency in English communication

Competencies:

• Strong communication and problem-solving skills
• Ability to manage multiple tasks in a fast-paced environment

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