Regulatory Affairs Manager, Medical Devices

Noctrix-Health; Pleasanton (CA); Híbrido; USD 150.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Health benefits

Hybrid work model

Descripción de la vacante

Noctrix Health in Pleasanton, CA seeks an experienced Manager, Regulatory Affairs to lead regulatory activities for medical devices across development, registrations, and post-market compliance. Hybrid, full-time role reporting to Senior VP Clinical & Regulatory Affairs, based at our Pleasanton headquarters.

The ideal candidate will manage FDA submissions (510(k) and international registrations), maintain registrations, review labeling, and coordinate cross-functional teams to ensure timely,

Formación

• Regulatory affairs experience in medical devices required.
• Experience with 510(k) submissions and international registrations.
• Strong regulatory documentation and writing skills.

Responsabilidades

• Lead regulatory submissions and maintain registrations globally.
• Collaborate with cross-functional teams to ensure compliance.
• Monitor regulatory changes and advise on impact.

Conocimientos

Regulatory submissions

FDA regulations

Project management

Technical writing

Cross-functional collaboration

Educación

Bachelor’s degree in Engineering/Life Sciences

Herramientas

FDA ESG

WebTrader

Descripción del empleo

Noctrix Health in Pleasanton, CA seeks an experienced Manager, Regulatory Affairs to lead regulatory activities for medical devices across development, registrations, and post-market compliance. Hybrid, full-time role reporting to Senior VP Clinical & Regulatory Affairs, based at our Pleasanton headquarters.

The ideal candidate will manage FDA submissions (510(k) and international registrations), maintain registrations, review labeling, and coordinate cross-functional teams to ensure timely,