Job Title: Director of Clinical, Regulatory Affairs, and Quality
Location: SF Bay Area

About Us

An innovative startup dedicated to advancing cutting-edge Class III medical devices. Our mission is to improve patient outcomes through groundbreaking technologies. As a growing organization, we are seeking a strategic and hands-on leader to oversee Clinical, Regulatory Affairs, and Quality functions.

Position Summary

The Director of Clinical, Regulatory Affairs, and Quality will play a pivotal role in driving the organization’s clinical strategies, regulatory submissions, and quality management systems. This cross-functional leader will ensure compliance with global regulatory requirements, maintain high standards of quality, and support the successful commercialization of our Class III medical device.

Key Responsibilities

Clinical Affairs

• Develop and implement clinical strategies to support regulatory submissions and market adoption.
• Oversee the design, execution, and reporting of clinical trials, ensuring compliance with GCP (Good Clinical Practice).
• Collaborate with KOLs (Key Opinion Leaders) and clinical investigators to drive engagement and advocacy.
• Analyze clinical data to support regulatory filings and inform product development.

Regulatory Affairs

• Lead the preparation, submission, and maintenance of regulatory filings, including IDEs, PMAs, and CE Mark applications.
• Serve as the primary liaison with regulatory agencies (e.g., FDA, EMA), managing interactions and negotiations.
• Monitor global regulatory changes and ensure compliance across markets.
• Provide strategic guidance to the product development team on regulatory requirements.

Quality Assurance

• Oversee the development and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards.
• Ensure timely resolution of quality issues, including CAPAs, audits, and supplier management.
• Drive a culture of quality across the organization, embedding best practices in processes and documentation.
• Prepare for and lead external audits and inspections by regulatory authorities.

Qualifications

• Bachelor’s degree in a relevant field (e.g., life sciences, engineering); advanced degree preferred.
• 10+ years of experience in clinical, regulatory, and quality roles within the medical device industry, including leadership experience.
• Demonstrated success with Class III medical devices and global regulatory pathways (e.g., FDA PMA, EU MDR).
• Strong knowledge of clinical trial design, regulatory submissions, and QMS requirements.
• Exceptional communication, leadership, and organizational skills.
• Experience working in a startup or high-growth environment is a plus.

What We Offer

• Opportunity to make a significant impact in a fast-paced, innovative startup.
• Competitive salary and equity package.
• Comprehensive health benefits and flexible work environment.