Director of Quality Assurance & Regulatory Affairs

Posted 11 December 2024
LocationUnited States of America
Job type Permanent
Reference208373
Contact NameDaniel Enright

Job description

Job Title: Director of Quality Assurance and Regulatory Affairs
Location: San Francisco Bay Area
Compensation: Competitive salary and benefits with equity/stock options
About the Company:
Founded by experienced MedTech entrepreneurs, this well-funded innovative MedTech startup, is entering its next phase of growth, aiming for FDA clearance through 510(k) submission. With the focus on groundbreaking medical imaging, the company is at the forefront of product development, combining cutting edge AI-driven software to upgrade the existing Medical Imaging equipment to enable enhanced clinical outcomes and broader patient’s access to advanced medical treatment.
About the Role:
The Director of Quality Assurance and Regulatory Affairs will lead the company’s Quality and Regulatory functions, ensuring compliance with FDA regulations and driving the organization toward successful FDA 510(k) submissions. The ideal candidate will bring deep experience in medical device development, strong technical expertise, and the ability to establish and scale processes in a fast-paced environment.
Key Responsibilities:
  • Quality Assurance Leadership:
    • Develop, implement, and oversee the company’s Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, and other relevant standards.
    • Lead quality processes, including design control, risk management, and CAPA systems.
    • Drive a culture of quality across all aspects of the organization.
  • Regulatory Affairs:
    • Develop and execute regulatory strategies for FDA 510(k) submissions, working collaboratively with internal teams and external consultants.
    • Ensure compliance with applicable medical device regulations throughout product development and commercialization.
  • Cross-Functional Collaboration:
    • Partner with R&D, Operations, and Product Development teams to align quality and regulatory objectives with business goals.
    • Work closely with the CTO to support product development efforts in mechanical and electronic engineering.
    • Assist in scaling the organization’s documentation processes and ensuring robust verification and validation practices.

Qualifications:
  • Experience:
    • Minimum of 8 years of Quality Assurance and Regulatory Affairs experience in the medical device industry, including leadership roles.
    • Minimum of 5 years of experience in product development as a part of R&D team, industrial engineering, or operations, preferably withing regulated industry.
    • Proven experience with FDA 510(k) submissions and regulatory pathways.
  • Technical Expertise:
    • Mechanical, Electrical or Software Engineering knowledge and practical experience.
    • Hands-on experience with verification and validation activities.
    • Experience in medical devices, that include software, hardware and disposables or implants.
  • Skills:
    • Ability to build, manage, and mentor high-performing teams.
    • Excellent documentation skills with a detail-oriented approach.
    • Strong communication skills to work effectively with internal teams and regulatory bodies.
What We Offer:
  • The opportunity to join a high-impact MedTech startup at a pivotal stage of growth.
  • Equity/stock options to share in the company’s success.
  • Collaborative, innovative culture with a focus on quality and excellence.