Global Regulatory Affairs Lead - FDA Submissions

glidewelldental; Irvine (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Glidewell Dental seeks an experienced Sr. Regulatory Affairs Specialist to lead FDA 510(k)/PMA filings and maintain global registrations. You will drive compliance, support audits, and collaborate with technical teams to ensure products meet regulatory standards.

You will interpret regulations, manage complex documentation, and guide teams through compliance requirements in a fast-moving, innovative environment in Irvine, CA.

Qualifications

• Bachelor’s degree in related field preferred.
• Minimum five (5) years of experience in Regulatory Affairs.
• Experience with FDA 510(k) and PMA filings is required.
• Knowledge of EU regulatory requirements (CE, MDD/IVD) is a plus.

Responsibilities

• Prepare and submit FDA registrations and submissions (510(k), PMA).
• Maintain US, Canada, and EU device listings and registrations.
• Support internal and external audits and document control.
• Develop and update SOPs for RA/QA processes.
• Collaborate with technical teams to ensure regulatory compliance.

Skills

FDA submissions

Regulatory affairs

Quality systems

Data analysis

Education

Bachelor’s degree

Tools

MS Office

Job description

Glidewell Dental seeks an experienced Sr. Regulatory Affairs Specialist to lead FDA 510(k)/PMA filings and maintain global registrations. You will drive compliance, support audits, and collaborate with technical teams to ensure products meet regulatory standards.

You will interpret regulations, manage complex documentation, and guide teams through compliance requirements in a fast-moving, innovative environment in Irvine, CA.