Director, Quality & Regulatory Compliance

DDS Lab; Tampa (FL); Hybrid; USD 150,000 - 190,000; Full time

Job summary

DDS Lab in Tampa, FL is seeking a Director of Quality and Regulatory to lead the Quality Management System (QMS) and ensure compliance with ISO 13485 and 21 CFR Part 820 across the organization. You will drive customer complaint handling, CAPA processes, KPI reporting, and cross-functional quality initiatives.

This leadership role partners with Operations, Sales, Finance, Product Management and HR to deliver data-driven quality outcomes and support regulatory submissions for new products as

Qualifications

• Bachelor’s degree in a relevant field or equivalent.
• 5+ years of leadership in quality, regulatory, or operations.
• Experience with ISO 13485 and 21 CFR Part 820 preferred.
• Strong analytical, technical writing, and process-improvement skills.

Responsibilities

• Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) to ensure regulatory compliance.
• Own the customer complaint process from intake to closure, including CAPA when required.
• Establish, monitor, and report quality KPIs and drive action on trends and issues.
• Maintain controlled documents, quality manuals, procedures, SOPs, and training materials; ensure updates are implemented.
• Partner with Sales, Finance, Product Management, Operations, and HR to identify quality trends and drive improvements.
• Support regulatory submissions and market clearance activities when applicable.

Skills

Quality leadership

Regulatory knowledge

QMS development

Cross-functional collaboration

Analytical writing

Education

Bachelor’s degree in a relevant field

Job description

DDS Lab in Tampa, FL is seeking a Director of Quality and Regulatory to lead the Quality Management System (QMS) and ensure compliance with ISO 13485 and 21 CFR Part 820 across the organization. You will drive customer complaint handling, CAPA processes, KPI reporting, and cross-functional quality initiatives.

This leadership role partners with Operations, Sales, Finance, Product Management and HR to deliver data-driven quality outcomes and support regulatory submissions for new products as