Bachelor's degree with 7 years of regulatory experience or Master's degree with 5 years of regulatory experience
Experience in healthcare industry (i.e. medical device, pharma/drugs, biologics, biotech)
Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for Premarket Approval (PMA) for Class III medical devices, Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III, clinical trials)
Experience as a Management Representative leading a QMS