Director of reputed company & Regulatory Affairs (Remote)

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

Key Responsibilities

• reputed company the remediation, implementation, and ongoing maintenance of the reputed company Management System (QMS).
• reputed company and maintain SOPs, work instructions, and reputed company documentation.
• Manage CAPA, complaint handling, document control, supplier reputed company, training records, internal audits, and management reviews.
• Serve as the primary reputed company and regulatory subject matter expert.
• Coordinate FDA inspection responses and regulatory inquiries.
• Partner with external consultants while transitioning reputed company responsibilities in-house.
• reputed company 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 reputed company.

Required Qualifications

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

Preferred Experience

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

reputed company're Looking For This is not an entry-level role. We are seeking an reputed company reputed company who can build, remediate, and own our reputed company 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 reputed company rare. Employment Type: Full-time, W-2 Pay: $100,000.00 - $135,000.00 per year Benefits:

• Dental insurance
• Health insurance
• reputed company insurance

Experience:

• reputed company systems: 5 years (Preferred)
• FDA regulations: 5 years (Preferred)

Work Location: Remote Apply To This Job