Regulatory Affairs Specialist II
Fractyl Health- Bachelor’s degree in Scientific, Engineering, Public Health, or a related field - RAPs Certification preferred - Minimum of 3 years of direct experience in Regulatory Affairs or a related field - Background in medical devices, biologics, or pharmaceutical industries (medical devices preferred) - Strong understanding of FDA and EU regulations and guidance documents - Knowledge of Quality System requirements such as QSR, ISO 13485, GxP - Solid technical writing skills with experience preparing r…
Salary not specified
Full Time
Mid-level (3 to 4 years)