CEFALY Technology

Compliance

• 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

Director, Quality Systems – Regulatory Affairs

Inside Sales

• Serve as the main interface for institutional customers through phone, email, and video conferencing.
• Act as the primary customer contact for assigned accounts.
• Conduct customer discovery and coordinate follow-up training with Cefaly Regional Trainers.
• Travel on-site to provide high-quality training to healthcare providers.
• Schedule and follow up on Regional Trainer in-service meetings.
• Process and track customer orders accurately.
• Work collaboratively with Customer Service to resolve questions, issues, and complaints.
• Use initiative to improve personal skills and departmental processes.
• Convert prospects into active customers.
• Works collaboratively with Inside Sales Representatives & Trainers.
• Represent CEFALY Technology at trade shows and medical conferences.
• Adapt to evolving business needs and take on other duties as required.
• Generate new leads and maintain accurate contact information in Salesforce.
• Perform additional duties as assigned.

Director, Quality Systems – Regulatory Affairs

Inside Sales & Training Associate