Remote Director, Quality Systems & Regulatory Affairs

Visa Hunt; United States; Hybrid; USD 160,000 - 180,000; Full time

Benefits offered by this job

Health insurance (80% employer-paid)

Dental and Vision (employer-paid)

Disability insurance (short/long-term)

Group Life Insurance

IRA with company match

Paid PTO and holidays

Job summary

CEFALY Technology is seeking a Director of Quality Systems & Regulatory Affairs on a remote or hybrid basis (East Coast only). The role leads QMS/eQMS, regulatory affairs, and audit readiness to enable scalable growth and compliance excellence across global markets.

The candidate will mentor QA/RA personnel, drive process improvements, and work with leadership to align quality with product development and supply chain priorities.

Qualifications

• Bachelor’s degree required in Engineering, Life Sciences, Regulatory Affairs, Quality or related field.
• Advanced degree preferred.
• Experience leading QMS/eQMS with regulatory compliance across global markets.

Responsibilities

• Lead QMS and eQMS platform ownership, governance, and user adoption.
• Manage audits including notified bodies, FDA inspections, and supplier assessments.
• Drive CAPA, change control, risk management, and documentation governance.
• Mentor junior QA/RA staff and partner with cross-functional teams across Operations, Supply Chain, and Product Development.
• Ensure compliance with ISO 13485, 21 CFR Part 820, EU MDR and related global regs.

Skills

QMS architecture

eQMS administration

Quality systems leadership

Audits & inspections

Regulatory strategy

Cross-functional collaboration

Process improvement

Documentation control

CAPA & change management

Education

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

Advanced degree preferred

Tools

Greenlight Guru

Job description

CEFALY Technology is seeking a Director of Quality Systems & Regulatory Affairs on a remote or hybrid basis (East Coast only). The role leads QMS/eQMS, regulatory affairs, and audit readiness to enable scalable growth and compliance excellence across global markets.

The candidate will mentor QA/RA personnel, drive process improvements, and work with leadership to align quality with product development and supply chain priorities.