Director, Quality Systems & Regulatory Affairs… at CEFALY… · Darien

Director, Quality Systems & Regulatory Affairs

Department: Quality & Regulatory Affairs

Reports To: SVP, Operations

Location: Remote or Hybrid - East Coast ONLY

FLSA Status: Exempt, Full-Time

Position Summary

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.

Essential Responsibilities

Quality Management System (QMS) & eQMS Leadership

• 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.

Audit & Compliance Leadership

• 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.

Regulatory Affairs Leadership

• 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.
• Support registrations, renewals, amendments, and post-market regulatory activities.
• Interpret changing regulatory requirements and proactively communicate implications.
• Maintain regulatory records and submission archives.

Leadership & Cross-Functional Partnership

• Mentor and help develop junior QA/RA personnel.
• Provide quality and regulatory leadership across Operations, Supply Chain, Customer Service, Product Development, and leadership teams.
• Act as an internal subject matter expert for QMS and regulatory requirements.
• Support employee training initiatives related to quality systems and compliance.
• Provide guidance during business, operational, and product decisions.

Qualifications

Education

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field required.
• Advanced degree preferred.

Experience

• 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.

Knowledge & Skills

• 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.

Preferred Certifications

• RAC, CQE, CQA, ASQ certifications, or equivalent preferred.

Success in this role includes:

• Complete a comprehensive assessment of current QMS and eQMS state.
• Develop and execute a Greenlight Guru optimization roadmap.
• Conduct a full controlled-document audit and remediation initiative.
• Reduce repeat audit observations and documentation inconsistencies.
• Improve notified body audit readiness and inspection confidence.
• Strengthen quality system governance and documentation control processes.
• Improve organizational QA/RA capability and mentorship support.
• Build scalable infrastructure supporting future growth.

Why This Role Matters

This role is being added to strengthen organizational quality and regulatory capabilities, reduce single-point dependency risk, improve QMS sustainability, and establish scalable systems supporting long-term growth and compliance excellence.

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