Director, QMS & Regulatory Excellence (Remote)

Cefaly; Darien (CT); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Dental and Vision

Disability insurance

Life Insurance

IRA with company match

Paid PTO

Paid holidays

Job summary

CEFALY Technology is seeking an experienced leader to strengthen the Quality Systems and Regulatory Affairs infrastructure, serving as the functional lead for QMS and Regulatory Affairs, driving compliance, audit readiness, and process maturation across the organization.

This role partners with Operations, Supply Chain, Customer Service, and Product Development to scale eQMS, coordinate FDA/Notified Body activities, and mentor a growing QA/RA organization toward scalable growth and regulatory

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field required or equivalent.
• Advanced degree preferred.
• 8–12+ years of progressive Quality and Regulatory Affairs experience within medical devices.

Responsibilities

• Act as primary Quality and Regulatory lead during notified body audits, FDA inspections, supplier audits, and external assessments.
• Lead audit preparation strategy, evidence collection, coordination activities, and response management.
• Drive audit finding remediation through root cause analysis and CAPA implementation.
• Mentor and develop junior QA/RA personnel.
• Provide guidance during business, operational, and product decisions.

Skills

Quality leadership

Regulatory affairs

Audit readiness

Documentation

Process improvement

Cross-functional collaboration

Project management

Regulatory knowledge

QMS administration

Data analysis

Education

Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field

Advanced degree

Tools

Greenlight Guru

Job description

CEFALY Technology is seeking an experienced leader to strengthen the Quality Systems and Regulatory Affairs infrastructure, serving as the functional lead for QMS and Regulatory Affairs, driving compliance, audit readiness, and process maturation across the organization.

This role partners with Operations, Supply Chain, Customer Service, and Product Development to scale eQMS, coordinate FDA/Notified Body activities, and mentor a growing QA/RA organization toward scalable growth and regulatory