RA&QA Lead

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.

RA&QA Lead:

The Regulation & Quality Assurance (RA & QA) Lead will oversee regulatory approvals and quality assurance for Mediwhale’s software-based medical AI products, including our flagship Dr.Noon platform. This role is not only responsible for navigating global regulatory pathways but also for building and leading a strong, collaborative team culture.

We are looking for a leader who respects expertise, listens actively, resolves conflicts effectively, and fosters collaboration across the organization.

Responsibilities:

• Lead communication within the team, mediate conflicts, and promote collaboration
• Identify team members’ strengths and support their growth
• Build and continuously improve quality assurance (QA) systems
• Manage regulatory timelines and mitigate risks to ensure on-time compliance
• Coordinate with internal development teams and external partners (CROs, PIs, etc.)
• Manage budgets and ensure cost-efficient operations
• Develop and execute regulatory strategies in compliance with global standards (FDA, MDR, etc.)

Qualifications:

• Proven ability to communicate effectively, mediate conflicts, and foster team collaboration
• Strong leadership in identifying strengths and supporting the growth of team members
• Experience in establishing and improving QA systems
• Skilled in managing regulatory deadlines and risk mitigation
• Experience coordinating with internal developers and external stakeholders (CROs, PIs, etc.)
• Budget management and cost-effective project execution
• Hands-on experience with regulatory strategies for global approvals (FDA, MDR, etc.)

Preferred:

• Experience with regulatory approvals for software-based medical devices
• Experience in regulatory approvals for clinically validated and evidence-based medical devices
• Leadership and organizational management experience in a startup environment
• Multinational collaboration experience

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
• Interviews: Each interview is expected to take approximately 30 to 50 minutes