Director of Quality & Regulatory Affairs (Remote)

Director of Quality & Regulatory Affairs (Remote) Candidates with direct experience leading FDA Warning Letter remediation, FDA Form 483 response activities, and quality system reconstruction in a medical device company are strongly preferred. About BlephEx BlephEx is a small but innovative medical device company focused on advancing the treatment of ocular surface disease and meibomian gland dysfunction. We are seeking an experienced quality and regulatory leader to help guide the company through a critical phase of growth, remediation, and regulatory advancement. This is a hands-on leadership role for an individual who has successfully built and managed FDA-compliant quality systems and has substantial experience with U.S. medical device regulatory requirements, including premarket submissions. Position Summary The Director of Quality & Regulatory Affairs will lead all aspects of the company's quality management system and regulatory strategy. This individual will work closely with executive leadership and outside consultants and attorneys to remediate existing quality system deficiencies, establish sustainable quality processes, and guide future regulatory activities, including FDA premarket submissions. This position is fully remote and reports directly to executive management.

Key Responsibilities

• Lead the remediation, implementation, and ongoing maintenance of the Quality Management System (QMS).
• Develop and maintain SOPs, work instructions, and quality documentation.
• Manage CAPA, complaint handling, document control, supplier quality, training records, internal audits, and management reviews.
• Serve as the primary quality and regulatory subject matter expert.
• Coordinate FDA inspection responses and regulatory inquiries.
• Partner with external consultants while transitioning quality responsibilities in-house.
• Develop and execute U.S. regulatory strategies and support 510(k) submissions.
• Support clinical study planning and regulatory documentation.
• Advise executive leadership on regulatory risks and compliance strategy.

Required Qualifications

• 8–10+ years of medical device quality/regulatory experience.
• Demonstrated experience developing, implementing, or remediating FDA-compliant quality systems.
• Significant experience with FDA regulations and 510(k) submissions.
• Experience responding to FDA inspections or enforcement actions strongly preferred.
• Ability to independently lead complex quality and regulatory initiatives.

Preferred Experience

• Class I and Class II medical devices.
• Quality system remediation following FDA inspections.
• Small-company environment with broad ownership.
• RAC or ASQ certifications are a plus.

What We're Looking For

This is not an entry-level role. We are seeking an experienced professional who can build, remediate, and own our quality and regulatory functions while helping establish a sustainable compliance infrastructure. Location: Remote (U.S.), travel to our office in Nashville, TN may be required, but would be very rare. Employment Type: Full-time, W-2 Pay: $100,000.00 - $135,000.00 per year Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Experience:

• Quality systems: 5 years (Preferred)
• FDA regulations: 5 years (Preferred)

Work Location: Remote