We are a biotechnology company focused on developing innovative genomic solutions for precision medicine in oncology. We are seeking a highly motivated REGULATORY AFFAIRS MANAGER to join us.
The job purpose is to lead and oversee all regulatory activities related to the development, approval, and commercialization of the company in vitro medical devices. The Regulatory Affairs Manager ensures implementation of Quality Management System, compliance with applicable regulations (such as IVDR, ISO 13485, and FDA guidance), manages regulatory submissions and audits, and contributes to the overall strategy...