Director, Regulatory Affairs and Quality Assurance

Overview

Key role in shaping regulatory affairs and quality assurance for product development.

Ideal candidate should have 8+ years of experience in regulatory affairs for medical devices and a proven track record with FDA submissions.

We are not considering candidates residing in Alaska, Arkansas, Delaware, Iowa, Mississippi, Missouri, Nebraska, Rhode Island, South Dakota, Vermont, West Virginia, and Wisconsin

Locations

• United States, California, San Francisco

Requirements

• Bachelor's degree required
• 8+ years of regulatory affairs experience
• Proven track record of successful FDA submissions
• Deep understanding of software as a medical device regulations
• Excellent leadership and communication skills

Responsibilities

• Lead regulatory and quality strategy
• Ensure compliance with FDA and CE
• Serve as liaison with regulatory agencies
• Guide regulatory filings
• Oversee post-market surveillance
• Build and manage RA/QA team
• Monitor regulatory changes
• Ensure effective Quality Management System

Benefits

• Competitive salary and equity packages
• Health, dental, vision insurance
• Paid time off and holidays
• Paid sick leave and parental leave
• Employee discounts