Senior Regulatory Specialist

clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II... completion of IDE and PMA submissions for IDE clinical trials Helps to prepare PMA packages, including non-clinical...

Lugar: USA | 14/11/2025 22:11:02 PM | Salario: S/. No Especificado | Empresa: NuVasive

Vice President, Quality Assurance

environments is mandatory Demonstrated experience in obtaining FDA approval for IDE/PMA and IND/NDA/BLA therapies is mandatory...

Lugar: Woburn, MA | 14/11/2025 21:11:00 PM | Salario: S/. No Especificado | Empresa: Sirtex

Lead Regulatory Affairs Specialist

and submission of regulatory premarket applications, and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions...(k) documents and responding to the FDA in a timely manner Assists in the completion of IDE and PMA submissions for IDE clinical...

Lugar: USA | 14/11/2025 21:11:18 PM | Salario: S/. No Especificado | Empresa: NuVasive