Global Regulatory Affairs Lead, Medical Devices (Onsite)

Pulse Staffing Limited; Hayward (CA); Presencial; USD 160.000 - 210.000; Jornada completa

Descripción de la vacante

Pulse Biosciences in Hayward, CA is seeking a Principal Global Regulatory Affairs Specialist to lead regulatory strategy for general, cardiac, and dermatology medical devices on-site. You will coordinate submissions to FDA and EU authorities, ensure MDR and ISO 13485 compliance, and guide cross-functional teams through complex pathways, including post-market obligations. This is a senior, global lifecycle role with health authority interactions.

Responsabilidades

• Lead regulatory strategy for general, cardiac, and dermatology medical devices on a global scale.
• Coordinate submissions to FDA and EU authorities and ensure MDR and ISO 13485 compliance.
• Manage interactions with health authorities and Notified Bodies.
• Guide cross-functional teams through complex regulatory pathways, including post-market obligations.

Descripción del empleo

Pulse Biosciences is seeking a Principal Global Regulatory Affairs Specialist in Hayward, CA (onsite). You will drive global regulatory strategy for general, cardiac, and dermatology medical devices, coordinating submissions to FDA and EU authorities and ensuring compliance with MDR and ISO 13485.

You will lead interactions with health authorities, manage Notified Bodies, and guide cross-functional teams through complex regulatory pathways, including post-market obligations.