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.
AI-SaMD Team:
Mediwhale's development organization is structured into three teams: AI-SaMD, Solution, and Information Security. Among them, the AI-SaMD Team plays a central role in developing Software as a Medical Device (SaMD).
A SaMD product combines a core AI model with a wide range of surrounding capabilities, such as patient data management, authentication and security, report generation, and license management. The AI domain of the AI-SaMD Team carries out research and development on the AI models that sit at the heart of these products. To this end, the team invests in a data-centric approach and in building the research platform that supports it.
To achieve these goals together, the AI-SaMD Team is looking for individuals who are not limited to a specific technology, but who demonstrate flexible thinking, curiosity for new technologies, and a sense of responsibility in applying their skills. The AI-SaMD Team is committed to building an environment where such talent can fully immerse themselves and thrive.
Responsibilities:
Qualifications:
Preferred:
Benefits:
Flexible working conditions (flexible hours and remote work up to 2 days a week)
Remote work policies may change based on company circumstances or policies
Lunch stipend (regardless of work location), coffee, beverages, and snacks provided
Annual comprehensive health check-up
Additional leave in addition to statutory annual leave (e.g., birthday leave, family events)
Support for job-related books and professional courses
Application Process:
Application Screening 1st Interview 2nd Interview Final Offer
Tasks may be assigned according to the role, and the interview process may be subject to change.
Application materials: Open format (must include resume)
Please highlight your previous roles and specific contributions.
Job interview: Approximately 2 hours, focusing on past experiences and technical knowledge.
Some interviews may be conducted in English or held remotely.
| Location | Los Angeles, CA |
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.
Free resume templatesImprove your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.
Free resume builder