ClinicalRA 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 for domestic, European, and other international markets
• Engage with regulatory authorities and manage relationships
• Manage and collaborate with domestic/international consultants
• Collaborate and coordinate with various internal stakeholders including product development and research organizations
• Track the latest regulatory standards and guidelines, and continuously monitor regulatory compliance
• Support post-market surveillance activities
• Support US FDA approval and registration tasks
• Support the establishment and maintenance of quality management system

Responsibilities:

• Bachelor's degree or higher in Pharmacy, Life Sciences, Engineering, or Computer Science
• Minimum of 5 years of experience in regulatory affairs within the medical device or pharmaceutical industry, both domestically and internationally
• In-depth understanding of Medical Device act, Digital Act, EU MDR, ISO 13485, US FDA guidance, and other regulatory requirements

Benefits:

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

• Remote work policies may change based on company circumstances or policies

• 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

※ We collect submitted documents solely for conducting the recruitment process and notifying applicants of the results. Documents will be returned upon request. All submitted materials will be securely destroyed within 180 days of the job posting closure. Requests for document return can be made via the recruitment website or at hr@mediwhale.com.