Senior QA & Regulatory Compliance Lead

Arkray Group; Florida; On-site; USD 95,000 - 150,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K

FSA

HSA

Job summary

AR RAY in Doral, FL is seeking an experienced Regulatory Affairs professional to lead pre-/post-market activities and ensure FDA submissions and registrations are compliant. The role requires strong knowledge of Class I/II medical devices and ISO 13485, with responsibilities spanning labeling review, supplier audits, and audit coordination.

The ideal candidate will manage FDA interactions, coordinate with customs, and support R&D and QA teams to drive compliant product launches while maintaining

Qualifications

• Bachelor’s-degree in chemistry, biology, engineering or a technical field.
• 2+ years in a regulated diagnostic industry.
• Senior roles require 7+ years in regulated diagnostics.
• Experience with Class I/II medical devices and US regulatory submissions.
• Knowledge of FDA, GMP/QSR, ISO, CFR and related regulatory issues.
• Ability to manage ISO 13485 audits and supplier audits.

Responsibilities

• Lead pre-/post-market regulatory activities and FDA submissions.
• Review labeling and coordinate with FDA and US Customs as needed.
• Manage FDA facility registrations and device listings.
• Oversee Quality System databases and internal audits.
• Coordinate CAPA and supplier change control processes.
• Support cross-functional teams in product launches and regulatory questions.

Skills

Regulatory Affairs

FDA Knowledge

Quality Assurance

Documentation

Travel Flexible

Education

Bachelor’s Degree in chemistry, biology, engineering or other technical field

Two or more years of experience in regulated diagnostic industry

Seven+ years for senior roles in regulated diagnostics

Tools

Microsoft Office

Job description

AR RAY in Doral, FL is seeking an experienced Regulatory Affairs professional to lead pre-/post-market activities and ensure FDA submissions and registrations are compliant. The role requires strong knowledge of Class I/II medical devices and ISO 13485, with responsibilities spanning labeling review, supplier audits, and audit coordination.

The ideal candidate will manage FDA interactions, coordinate with customs, and support R&D and QA teams to drive compliant product launches while maintaining