Senior Global Regulatory Affairs Leader – Medical Devices

Pulse Biosciences, Inc.; Hayward (CA); Vor Ort; USD 160.000 - 190.000; Vollzeit

Benefits dieser Stelle

Stock options

ESPP

401k plan

Health insurance

Onsite gym

Zusammenfassung

Pulse Biosciences is seeking a Principal Global Regulatory Affairs Specialist to lead global regulatory strategies for general surgery, cardiac surgery, and dermatology devices. You will guide FDA, EU MDR, and ISO 13485 compliance and collaborate with cross-functional teams to ensure timely submissions and approvals.

You will manage technical documentation, post-market oversight, and interactions with health authorities, driving lifecycle management and regulatory excellence across markets.

Qualifikationen

• Bachelor's degree in Engineering or related discipline.
• 10+ years of Global Regulatory Affairs experience in medical devices/biotech.
• Experience with FDA PMA/510(k)/IDE submissions and EU MDR knowledge.
• Knowledge of ISO 13485 and QMS requirements.
• Willingness to travel up to 10% and work onsite in Hayward, CA.

Aufgaben

• Implement global regulatory strategies for general/plastic surgery, cardiology, and dermatology devices.
• Manage international regulatory affairs from creation to submission of Technical Files and CE marking.
• Support FDA regulatory submissions including 510(k)s, PMAs, IDEs, and agency interactions.
• Oversee product registration submissions and lifecycle management.
• Interact with regulatory agencies to expedite submissions and approvals.
• Monitor regulatory outcomes and advise senior management.
• Collaborate with clinical operations to ensure study results support submissions.
• Provide regulatory vigilance and AE assessment for MDR submissions.

Kenntnisse

Global Regulatory Affairs

Regulatory strategy

FDA submissions

EU MDR

Project management

Ausbildung

Bachelor's degree in Engineering

Master's degree

Tools

Microsoft Office Suite

Jobbeschreibung

Pulse Biosciences is seeking a Principal Global Regulatory Affairs Specialist to lead global regulatory strategies for general surgery, cardiac surgery, and dermatology devices. You will guide FDA, EU MDR, and ISO 13485 compliance and collaborate with cross-functional teams to ensure timely submissions and approvals.

You will manage technical documentation, post-market oversight, and interactions with health authorities, driving lifecycle management and regulatory excellence across markets.