[Remote] Director Quality Assurance Regulatory Affairs

Note: The job is a remote job and is open to candidates in USA. Meet Life Sciences is recruiting a senior Quality and Regulatory leader for a commercial-stage medical device organization. The Director will own and continuously improve the Quality Management System while leading postmarket Quality Assurance, Regulatory Affairs, surveillance, inspections, commercial regulatory operations, and AI-enabled medical device lifecycle compliance.

Responsibilities

• Own and continuously improve the Quality Management System, ensuring alignment with FDA QMSR / 21 CFR Part 820 and ISO 13485
• Act as Management Representative and lead Management Review, internal audits, document control, training and quality data analysis
• Lead FDA inspection and third-party audit readiness, including remediation and effectiveness of findings
• Oversee complaint handling, MDR/reportability, postmarket surveillance, CAPA and field issue management
• Lead postmarket PMA regulatory strategy, including supplements, annual reports and Predetermined Change Control Plans (PCCPs)
• Oversee commercial regulatory requirements including establishment registration, device listing, UDI/GUDID and labelling
• Support product lifecycle changes, market expansion and regulatory agency interactions
• Provide oversight of AI/ML model performance, retraining, validation and release within approved regulatory pathways
• Ensure postmarket cybersecurity requirements are effectively managed
• Provide regulatory oversight of promotional, external and investor-facing materials
• Lead and develop the Quality & Regulatory Affairs function

Skills

• 15+ years' experience across Quality Assurance and Regulatory Affairs within Class II/III medical devices
• Strong experience operating within FDA and ISO 13485-compliant QMS environments
• Proven experience with Class III / PMA-approved devices and postmarket lifecycle management
• Experience owning complaint handling, MDR decision-making, CAPA and FDA inspections
• Experience with AI/ML-enabled medical devices, PCCPs and GMLP principles
• Knowledge of medical device software lifecycle management (IEC 62304)
• Experience with postmarket cybersecurity requirements for connected devices
• Strong understanding of US postmarket surveillance requirements
• Experience with global registrations and international market expansion is highly desirable
• ISO 13485 Lead Auditor certification would be advantageous

Benefits

• US Remote

Company Overview

• Meet Life Sciences is a global leader in providing bespoke talent solutions to the life sciences industry. It was founded in 2009, and is headquartered in London, England, GBR, with a workforce of 51-200 employees. Its website is https://www.peoplewithchemistry.com/.

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