Regulatory Affairs & Quality Systems Director

Xenter; Draper (UT); On-site; USD 150,000 - 200,000; Full time

Job summary

Xenter, a technology in medicine company based in Draper, Utah, seeks a Director of Regulatory Affairs & Quality Systems. The position involves setting global regulatory strategies, managing quality systems compliant with ISO standards, and ensuring the organization is ready for FDA inspections and public company scrutiny. Candidates should have 15+ years of experience in the medical device field and a Bachelor’s degree in relevant disciplines. An advanced degree is preferred for this leadership role.

Qualifications

• 15+ years of progressive regulatory affairs and quality systems experience in medical devices and software.
• Demonstrated track record leading FDA submissions and agency interactions at a senior level.
• Extensive knowledge of regulatory frameworks and quality management.

Responsibilities

• Set and own global regulatory strategy across the product portfolio.
• Lead regulatory submissions and interactions with FDA.
• Oversee quality systems compliance with ISO standards.

Skills

Regulatory submissions

Quality management systems

Leadership

FDA knowledge

Risk management

Education

Bachelor's degree in life sciences, engineering or related field

Advanced degree

Tools

ISO 13485

21 CFR Part 820

Job description

Xenter, a technology in medicine company based in Draper, Utah, seeks a Director of Regulatory Affairs & Quality Systems. The position involves setting global regulatory strategies, managing quality systems compliant with ISO standards, and ensuring the organization is ready for FDA inspections and public company scrutiny. Candidates should have 15+ years of experience in the medical device field and a Bachelor’s degree in relevant disciplines. An advanced degree is preferred for this leadership role.