Global Regulatory Affairs Lead, Medical Devices (Onsite)

Pulse Staffing Limited; Hayward (CA); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Stock options

Employee Stock Purchase Plan (ESPP)

Comprehensive benefits

Onsite gym and wellness

Job summary

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.

Qualifications

• Bachelor’s degree in Engineering, life sciences or equivalent.
• 10+ years in global regulatory affairs for medical devices/biotech.
• Experience with PMA submissions and CE Marking under MDR.
• Regulatory experience in general/plastics surgery, cardiology, or dermatology devices preferred.
• Experience with Notified Bodies, Authorized Representatives and regulatory intelligence.
• Willingness to travel up to 10%.

Responsibilities

• Develop and execute global regulatory strategies across multiple indications.
• Oversee FDA submissions (510k, PMAs) and EU MDR documentation.
• Interact with health authorities and cross-functional teams to accelerate approvals.
• Lead lifecycle regulatory activities and post-market surveillance.
• Ensure compliance with MDCG, ISO 13485 and QMS requirements.

Skills

Global Regulatory Affairs

Regulatory strategy

FDA QSR/510(k)

EU MDR knowledge

Medical devices

Education

Bachelor’s degree in Engineering or life science

Master’s degree in related field

Job description

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.