Senior Quality & Regulatory Leader (Hybrid)

ProEdge Dental; Centennial (CO); Hybrid; USD 140,000 - 175,000; Full time

Benefits offered by this job

Salary $140k–$175k per year

Job summary

ProEdge Dental Compliance Labs is seeking a Head of Quality & Regulatory to own the Quality Management System and serve as Management Representative. You will lead a small team, face FDA and EPA on our behalf, and report to the President.

You will drive product launch readiness, supplier quality, and prevention-focused improvements across the organization, embedding quality as a strategic partner and ensuring compliance with 21 CFR 820 and ISO 13485.

Qualifications

• 8+ years in medical device quality including 3+ as accountable quality lead or Management Representative.
• You've hosted an FDA inspection and answered tough questions with preparedness and honesty.
• You know 21 CFR 820 (QMSR), ISO 13485, ISO 14971, and the obligations of initial importer (21 CFR 803/807).
• You have written investigations, conducted audits, or made release decisions in the last two years.
• You have led quality programs that measurably reduced defects, recurrence, or variability and can explain the prevention approach.

Responsibilities

• Own the QMS end-to-end, including CAPA, complaints, MDR, and management review.
• Be the face to regulators (FDA, EPA) and readiness for inspections.
• Lead new product launch readiness with risk management and process validation.
• Maintain supplier and co-manufacturer quality expectations and risk management.
• Drive prevention through SPC, root-cause analysis, and cross-functional collaboration.
• Embed a culture of quality as a strategic partner across the organization.

Skills

Quality leadership

FDA inspection experience

Regulatory knowledge

CAPA/Complaints/MDR

Management Representative

Education

8+ years in medical device quality

Job description

ProEdge Dental Compliance Labs is seeking a Head of Quality & Regulatory to own the Quality Management System and serve as Management Representative. You will lead a small team, face FDA and EPA on our behalf, and report to the President.

You will drive product launch readiness, supplier quality, and prevention-focused improvements across the organization, embedding quality as a strategic partner and ensuring compliance with 21 CFR 820 and ISO 13485.