Director, Quality Systems – Regulatory Affairs

• Serve as system owner and business lead for the organization’s eQMS platform including optimization, implementation expansion, workflow design, governance, and user adoption
• Assess current eQMS utilization and develop a roadmap for full implementation and process maturity
• Own and administer day‑to‑day QMS and eQMS activities and processes
• Lead continual improvement initiatives across quality system processes and documentation
• Lead comprehensive audits of controlled documentation and quality records to identify inconsistencies, gaps, obsolete content, and systemic documentation deficiencies
• Establish processes and controls ensuring consistency across SOPs, work instructions, forms, labels, templates, and quality records
• Drive document control processes including creation, revision workflows, review cycles, training assignments, archival activities, and change management
• Develop sustainable document governance practices to reduce repeat nonconformances and improve inspection readiness
• Monitor quality metrics and identify opportunities for process improvements
• Support and improve CAPA, nonconformance, complaint handling, change control, risk management, and supplier quality processes
• Ensure QMS alignment with ISO 13485, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and applicable global requirements
• Lead initiatives to improve quality system effectiveness, data integrity, and organizational compliance maturity
• Maintain ongoing inspection and audit readiness
• Act as primary Quality and Regulatory lead during notified body audits, FDA inspections, supplier audits, and external quality assessments
• Lead audit preparation strategy, evidence collection, coordination activities, and response management
• Drive audit finding remediation through root‑cause analysis and sustainable CAPA implementation
• Support management review processes and quality reporting
• Maintain a continuous state of organizational inspection readiness
• Independently lead FDA and international regulatory submissions and agency interactions
• Prepare, coordinate, and execute regulatory filings and lifecycle submissions
• Conduct regulatory impact assessments related to product, process, manufacturing, supplier, labeling, and operational changes
• Provide regulatory strategy recommendations and communicate business impact to leadership
• Mentor and help develop junior QA/RA personnel
• Provide quality and regulatory leadership across Operations, Supply Chain, Customer Service, Product Development, and leadership teams

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field required
• Advanced degree preferred
• 8–12+ years of progressive Quality and Regulatory Affairs experience within medical devices
• Demonstrated experience serving as lead quality or regulatory representative during notified body audits and regulatory inspections
• Proven experience owning, implementing, or significantly improving an electronic QMS platform; Greenlight Guru experience strongly preferred
• Demonstrated experience identifying and remediating systemic documentation and quality system deficiencies
• Experience independently leading FDA submissions and EU MDR activities
• Experience with CAPA, complaint handling, risk management, supplier quality, document control, and change management systems
• Demonstrated success improving audit outcomes and quality system maturity
• Prior people leadership or mentoring experience strongly preferred
• Experience supporting Class II and/or Class III medical devices preferred

Core Competencies

Demonstrates expertise in Quality Management Systems (QMS) and electronic QMS platforms, with a strong focus on regulatory compliance, audit readiness, and process improvement within the medical device industry. Proven ability to lead cross‑functional teams and mentor junior personnel while driving quality initiatives and ensuring alignment with ISO 13485 and FDA regulations.