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 this exciting juncture, we invite a skilled US RA to join our vibrant team, play a pivotal role in our novel initiatives, and develop alongside us.

• Coordinate regulatory activities related to the product lifecycle for marketing approvals in accordance with regulations and relevant guidelines (notifications, certifications, approvals as well as compliance with all necessary post-market surveillance activities)
• Liaise with regulatory authorities, agencies, and local/global consultants; establishment and continuation of a regulatory network
• Coordinate tasks across multiple departments along with an understanding of all aspects in product development, including research, clinical development, manufacturing practices, regulations, and approval processes
• Determine and manage regulatory submissions or internal documentation that are required for proposed device changes or labeling changes aligned with disciplined regulatory compliance
• Monitor scientific and legal documents, including regulatory standards and guidelines and ensuring compliance with the regulations set by the regulatory authorities

Qualifications:

• Minimum of Bachelor’s degree majored in pharmacy, bioengineering, biomedical engineering, or computer science related field
• 3+ years of experience in Regulatory Affairs and/or Quality Assurance for medical device or pharmaceuticals
• Strong knowledge of regulatory requirements in US, EU (MDD/MDR) regulations

Preferred:

• Experience in SaMD products and its regulatory requirements
• Proficient English in written and verbal communication skills
• Experience with the preparation and completion of US, EU, or international regulatory submissions (i.e., 510(k), PMA, MDD/MDR)

Benefits:

• Flexible working conditions including work-from-home (2 days per week)
• Company supported daily lunch and snacks
• Annual comprehensive health check-up
• Support for congratulatory or condolence expenses
• Medical expense support (covered by group insurance)
• 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)
• Interviews: Each interview is expected to take approximately 30 to 60 minutes.
  • Some interviews may be conducted in English or through video call.