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Position Summary:
- Lead Quality Systems and Regulatory Affairs to improve compliance and reduce risk.
- Optimize eQMS and drive process improvements across the organization.
- Partner with cross-functional teams to ensure scalable growth.
Essential Responsibilities:
- Serve as eQMS system owner and lead audit preparation and regulatory submissions.
- Drive document control, CAPA, risk management, and supplier quality processes.
- Maintain inspection readiness and mentor junior personnel.
Qualifications:
- 8-12+ years of progressive QA/RA experience in medical devices.
- Deep knowledge of ISO 13485, FDA QSR, and EU MDR.
- Experience with Greenlight Guru and independent FDA submissions.
Benefits:
- Health insurance (80% employer-paid), dental, vision.
- Disability, life insurance, IRA with match (no vesting).
- Paid PTO and holidays.
CEFALY Technology
CEFALY Technology develops medical devices for migraine relief. It is a growing organization that values quality, compliance, and mentorship.