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SleepRes™, Inc. · 6 hours ago

Director of Quality and Regulatory Affairs

San Francisco, CA

Full-time

Hybrid

Director/Executive

7+ years exp

SleepRes™, Inc. is seeking a Director of Quality and Regulatory Affairs to oversee and manage the quality and regulatory functions of their sleep and respiratory medical devices. This role is responsible for developing quality systems, ensuring regulatory compliance with FDA and ISO standards, and leading a high-performing team.

Health CareMedicalMedical DeviceWholesale

Responsibilities

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 strategies to identify and mitigate medical device hazards

Ensure compliance with ISO 14971 risk management requirements

Ensure risk assessments are conducted across the product development process

Lead post-market risk evaluation and field corrective actions when required

Qualification

Quality Management System (QMS)FDA regulationsISO 13485510(k) submissionsDesign ControlsCAPA managementISO 14971 risk managementSupplier qualityPost-market surveillanceAnalytical skillsLeadership skillsCommunication skillsInterpersonal skillsTeam management

Required

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 13485 audits

Hands-on experience with Design Controls, CAPA, risk management, and post-market surveillance

People management and cross-functional leadership experience

Preferred

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

Company

SleepRes™, Inc.

SleepRes, based in Murfreesboro, Tennessee, is developing game-changing technologies aimed at improving outcomes for patients with pulmonary and sleep disorders.

Founded in 2022

Murfreesboro, Tennessee, USA

11-50 employees