Senior Regulatory Affairs Lead - Class III PMA Submissions

Shifamed; Los Gatos (CA); Híbrido; USD 150.000 - 210.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Equity

Hybrid work

Descripción de la vacante

Shifamed in Los Gatos, CA seeks a Principal Regulatory Affairs Specialist to lead US, EU, and Japan regulatory activities for a class III mechanical circulatory support device. The role focuses on submission strategy, planning, and writing with the Supira Medical team and consultants.

You will write major submissions (IDE, PMA, EU Design Dossiers, Shonin), coordinate priorities, guide the regulatory team, and ensure ongoing compliance.

Responsabilidades

• Writing major submissions (IDE, PMA, EU Design Dossiers, Shonin).
• Coordinating regulatory priorities and guiding the team.
• Ensuring regulatory compliance across US, EU, and Japan.

Descripción del empleo

Shifamed is seeking a Principal Regulatory Affairs Specialist in Los Gatos, CA to lead US, EU, and Japan regulatory activities for a class III mechanical circulatory support device. The role focuses on submission strategy, planning, and writing with Supira Medical team and consultants.

Responsibilities include writing major submissions (IDE, PMA, EU Design Dossiers, Shonin), coordinating priorities, guiding team, and ensuring regulatory compliance; hybrid work, competitive salary, equity.