Director, Clinical Affairs - Minimally Invasive Surgery

Pulse Staffing Limited; Hayward (CA); Hybrid; USD 190,000 - 250,000; Full time

Benefits offered by this job

Health insurance plans

401k retirement savings plan

Stock options awards

Employee Stock Purchase Plan (ESPP)

Paid time off and holidays

Flexible work schedule

Job summary

Pulse Biosciences, Hayward, CA, seeks a Director of Clinical Affairs for the Minimally Invasive Surgery Market. Lead strategic clinical programs for Thyroid and related indications with oversight of regulatory compliance and trial execution.

You will manage cross-functional teams, partner with CROs, and drive project timelines, budgets, and data integrity for FDA submissions and publications. Hybrid work with substantial travel may apply.

Qualifications

• 10+ years of progressive industry experience with medical devices.
• 5+ years clinical trial management experience with class II/III devices.
• Experience in ablation devices and IDE/PMA submissions is a plus.

Responsibilities

• Plan, direct and execute the minimally invasive surgery market portfolio.
• Ensure compliance with GCP, SOPs, and regulatory guidance.
• Manage CROs, Core Labs, and trial budgets.

Skills

Clinical trial mgmt

GCP/ICH knowledge

Regulatory strategy

Leadership

Education

BS/BA in Life Sciences

RN/BSN (optional)

Tools

EDC systems

FDA regulatory submissions

Job description

Pulse Biosciences, Hayward, CA, seeks a Director of Clinical Affairs for the Minimally Invasive Surgery Market. Lead strategic clinical programs for Thyroid and related indications with oversight of regulatory compliance and trial execution.

You will manage cross-functional teams, partner with CROs, and drive project timelines, budgets, and data integrity for FDA submissions and publications. Hybrid work with substantial travel may apply.