Regulatory Strategy Lead — Autonomous Surgical Robot

Remedy Robotics; San Francisco (CA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Remedy Robotics, located in San Francisco, seeks a Regulatory Affairs Lead to shape regulatory strategy and author FDA submissions for an innovative autonomous surgical device. This hands-on role involves direct collaboration with the CEO and key teams to navigate the FDA's rigorous approval processes.

The ideal candidate has over 10 years of experience within regulatory affairs in medical devices, strong FDA interaction skills, and a relevant educational background. Join us in transforming the future of surgical intervention.

Qualifications

• 10+ years in regulatory affairs at medical device companies.
• Direct experience with FDA Class III device submissions.
• Strong knowledge of FDA regulations and ISO standards.

Responsibilities

• Own the regulatory roadmap from IDE through market authorization.
• Serve as primary FDA contact for submissions and inquiries.
• Author IDE submission and lead cross-functional teams.

Skills

Regulatory affairs in medical devices

FDA submissions (Class III)

Excellent written and verbal communication

Knowledge of 21 CFR Parts 812, 814, 820

Experience with AI/ML guidance

Education

Bachelor's degree

Advanced degree (MS, PhD, JD, MBA, RAC)

Job description

Remedy Robotics, located in San Francisco, seeks a Regulatory Affairs Lead to shape regulatory strategy and author FDA submissions for an innovative autonomous surgical device. This hands-on role involves direct collaboration with the CEO and key teams to navigate the FDA's rigorous approval processes.

The ideal candidate has over 10 years of experience within regulatory affairs in medical devices, strong FDA interaction skills, and a relevant educational background. Join us in transforming the future of surgical intervention.