[Hiring] Director, Quality Systems & Regulatory Affairs @CEFALY Technology

Role Description

CEFALY Technology is seeking an experienced Quality Systems & Regulatory Affairs leader to strengthen and scale the organization's quality and regulatory infrastructure. This individual will serve as the functional lead for Quality Systems and Regulatory Affairs and will be responsible for improving organizational compliance, strengthening audit readiness, and reducing quality system risk through robust process ownership and execution.

A critical priority for this role will be optimizing and expanding the company's electronic Quality Management System (eQMS), conducting comprehensive assessments of quality documentation and system effectiveness, and driving sustainable process improvements across the organization. This position will provide experienced leadership during notified body audits and regulatory inspections and will help build long-term organizational capability through mentorship and process maturity.

The role serves as a strategic and hands-on partner across Operations, Supply Chain, Customer Service, Product Development, and leadership teams to ensure compliance excellence and scalable growth.

Qualifications

• 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.

Requirements

• Deep understanding of ISO 13485, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and related global regulations.
• Strong understanding of quality systems architecture and eQMS administration.
• Excellent technical writing and documentation skills.
• Strong project management and organizational capabilities.
• Strong leadership presence during audits and external interactions.
• Ability to manage multiple priorities within fast-paced environments.
• Excellent communication and cross-functional influencing skills.
• Strong analytical, problem-solving, and systems-thinking abilities.

Benefits

• Health insurance (80% employer-paid)
• Employer-paid Dental and Vision
• Short-Term and Long-Term Disability
• Group Life Insurance
• IRA with company match (no vesting period)
• Paid PTO
• Paid company holidays