Senior Global Regulatory Affairs Lead — Medical Devices

Shifamed; California (MO); Hybrid; USD 150,000 - 180,000; Full time

Benefits offered by this job

Equity

Benefits

Job summary

Shifamed is seeking an experienced Regulatory Affairs Lead to oversee US, EU and Japan submissions for a class III medical device within Supira Medical’s portfolio. The role requires strategic planning, writing and submission management for IDE, PMA, EU Design Dossiers and Shonin, with close collaboration to the Supira regulatory team.

Hybrid work from our Los Gatos, CA office, leading cross‑functional teams across Clinical, R&D and Quality to ensure compliant submissions and regulatory pathway

Qualifications

• 8+ years of medical device regulatory affairs experience in US and EU.
• Strong US and EU submission structure and writing skills.
• Proficient knowledge of clinical trial strategy and sponsor reporting.

Responsibilities

• Plans, structures and completes writings of major regulatory submissions (IDE, PMA, EU Design Dossiers, Shonin).
• Leads submission strategy with cross-functional teams (Clinical, R&D, Quality).
• Provides technical guidance during submission planning and regulatory interactions.
• Oversees preparation, review and maintenance of regulatory files and labeling.
• Represents the company with regulators and coordinates communications.

Skills

Regulatory affairs

Project leadership

Technical writing

Communication

Job description

Shifamed is seeking an experienced Regulatory Affairs Lead to oversee US, EU and Japan submissions for a class III medical device within Supira Medical’s portfolio. The role requires strategic planning, writing and submission management for IDE, PMA, EU Design Dossiers and Shonin, with close collaboration to the Supira regulatory team.

Hybrid work from our Los Gatos, CA office, leading cross‑functional teams across Clinical, R&D and Quality to ensure compliant submissions and regulatory pathway