Post Market Specialist
Real Staffing are currently partnering with leading Medical Device/Digital Health organization based in Cupertino to find a post market analyst to join their Post Market team focusing specifically on their Korean and Asian markets.
This role is focused on post market surveillance working across the Quality, Regulatory and call centers to identify and run and coordinate investigations based on complaints. All thought being a major organization the regulatory and Post surveillance team are relatively new to the organization and being able to lead these investigation with recommendation rather than copy and paste will be key.
They are looking for someone who either speaks Japanese or Korean and the products are two well established apps focusing on heart monitoring.
- Read/Write in the Korean language
- Working CAPA investigations and closures previously in their career
- Experience working with he FDA in the past
- Experience working in a post market environment (after product launch)
- Working with a SaMD device is a plus but not necessary.
- Clear verbal/writing communications.
- Worked cross functionally with Quality teams as well as software and hardware teams.
Sthree US is acting as an Employment Business in relation to this vacancy.