- Cordis (Irvine, CA)
- …open to remote. MedAlliance (Cordis) are seeking a highly skilled and motivated Principal Regulatory Affairs Specialist to join our dynamic team. This role ... in preparing and submitting PMA modules for a Class III combination product. The ideal candidate will possess strong...strong clinical experience and a proven track record in regulatory affairs within the medical device industry.… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... years related experience; including but not limited to providing regulatory expertise in US PMA Class III ...providing regulatory expertise in US PMA Class III products, EU MDR, and working on product lifecycle… more
- Fujifilm (Santa Ana, CA)
- **Overview** We are hiring a Clinical Affairs Specialist . The Clinical Affairs Specialist will be responsible for assisting in the development and ... and in vitro diagnostic devices. In addition, the Clinical Affairs Specialist will assist in performing annual...updates to maintain EU product conformance (class IIb and III products) + Assist in providing evaluation of clinical… more