Director of Quality and Regulatory Affairs

Director of Quality and Regulatory Affairs

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The Director of Quality and Regulatory Affairs will report directly to the CEO and be responsible for developing, implementing, and maintaining quality systems and regulatory compliance processes in accordance with FDA regulations (21 CFR Part 820) and ISO 13485 standards. This role will own the Quality Management System (QMS) and ensure compliance across design, development, manufacturing, and post‑market surveillance activities. The position will serve as the primary contact during regulatory inspections and notified body audits and is critical to ensuring the safety, efficacy, and compliance of Sleep Res' sleep and respiratory medical devices.

• Quality Management System (QMS)
• Design Controls (DHF, DMR, DHR)
• 510(k) submissions and regulatory consultant collaboration
• FDA inspections and ISO 13485 audits
• ISO 14971 risk management
• CAPA management
• Supplier quality and incoming inspection
• Class II and Class III medical device compliance
• Complaint handling and post‑market surveillance
• Validation (IQ/OQ/PQ)
• Regulatory compliance strategy

• 7+ years of experience in Quality Assurance and Regulatory Affairs within the medical device industry.
• Experience working with Class II medical devices or higher (Class II, II+, or Class III).
• Experience preparing and submitting 510(k) submissions, including collaboration with regulatory consultants.
• Strong knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.
• Experience leading FDA inspections or ISO 1345 audits.
• Hands‑on experience with Design Controls, CAPA, risk management, and post‑market surveillance.
• People management and cross‑functional leadership experience.

• Experience with respiratory devices or CPAP systems.
• Early‑stage startup experience.
• Experience with electronic QMS (eQMS) systems.
• RAC certification or advanced degree in a related field.

• Oversee and manage the quality organization, including design assurance, manufacturing quality, customer feedback, supplier management, and audit compliance.
• Establish and maintain Key Process Indicators (KPIs) to measure quality performance and drive continuous improvement.
• Lead management reviews and ensure alignment with quality goals and objectives.
• Own the Design Control process (21 CFR 820.30), ensuring proper documentation of DHF, DMR, and DHR.
• Establish incoming inspection and supplier quality processes, including qualification, monitoring, and audits.
• Develop and maintain quality documentation including SOPs, Work Instructions, and quality records.
• Oversee complaint handling, MDR evaluation, and post‑market surveillance processes.

• Navigate the global regulatory landscape to ensure successful product approvals in various markets.
• Develop regulatory strategy for new products, modifications, and international market entry (EU MDR, Health Canada, etc.).
• Prepare regulatory filings, including 510(k) submissions and PMAs, with support from regulatory consultants as needed.
• Maintain regulatory documentation, including Technical Files and 510(k)/PMA support documents.
• Manage interactions with the FDA, including Q‑Sub meetings and audits.
• Review and approve labeling, IFU, claims, and marketing materials for regulatory compliance.
• Implement regulatory compliance strategy across the product lifecycle.

• Lead and develop a high‑performing quality and regulatory affairs team.
• Mentor team members on best practices in quality assurance and regulatory compliance.
• Partner closely with Engineering, Clinical, and Operations to integrate quality and regulatory requirements into product development.

• Conduct internal audits to verify compliance with quality standards and regulatory requirements.
• Work with Notified Bodies to establish and maintain ISO 13485 compliance.
• Manage CAPA processes to address non‑conformities and improve product quality.
• Serve as Management Representative for ISO 13485 and FDA Quality System Regulation.

• Implement risk management…