Senior Regulatory Affairs Lead - Class III PMA Submissions

Shifamed; Los Gatos (CA); Hybrid; USD 150,000 - 180,000; Full time

Benefits offered by this job

Equity

Benefits

Job summary

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.

Qualifications

• 10+ years in medical device regulatory affairs.
• Experience with IDE, PMA, EU Design Dossiers, and Japanese Shonin.
• Strong US/EU/Japan regulation knowledge and writing skills.
• FDA cardiovascular device experience preferred.
• Start-up/consulting exposure a plus.

Responsibilities

• Lead major regulatory submissions for US, EU, and Japan.
• Structure and manage submission strategies and timelines.
• Provide guidance to Supira team and consultants.
• Draft, review and edit submissions.
• Represent the company with regulators and stakeholders.
• Oversee labeling review and internal regulatory docs.
• Promote continuous improvement in quality and regulatory processes.

Skills

Regulatory affairs

PMA submissions

Global regulatory knowledge

Job description

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.