Senior Regulatory Lead — IDE/PMA Strategy | Hybrid + Equity

Shifamed; Los Gatos (CA); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Equity

Hybrid work

Job summary

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.

Responsibilities

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

Job description

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.