Remote FDA Regulatory Affairs Specialist – IVD

IMMY; Norman (OK); On-site; USD 70,000 - 110,000; Full time

Job summary

IMMY is seeking a Regulatory Affairs Specialist – FDA to lead US regulatory submissions for in vitro diagnostic products and secure required FDA clearances, registrations, listings, and licenses to keep products on the U.S. market.

The role emphasizes thorough documentation, cross-functional collaboration, and compliance with FDA and ISO 13485 standards. The ideal candidate has a bachelor’s degree in a related field with 2+ years in a US FDA-regulated environment, strong technical writing, and

Qualifications

• Bachelor’s degree in related discipline with 2+ years in a US FDA-regulated environment.
• Broad knowledge of US FDA medical device regulations and ISO 13485.
• Strong technical writing and oral communication skills.

Responsibilities

• Prepare and submit 510(k), PMA, De Novo, and EUA submissions with supporting documentation.
• Monitor regulatory status and renew registrations, listings, and licenses in the US.
• Coordinate with R&D and QA teams to ensure compliant product data.
• Maintain readiness for audits and FDA inquiries with thorough records.

Skills

Technical writing

Oral communication

Attention to detail

Multitasking

Team collaboration

Independent work

Education

Bachelor’s degree in related discipline

Job description

IMMY is seeking a Regulatory Affairs Specialist – FDA to lead US regulatory submissions for in vitro diagnostic products and secure required FDA clearances, registrations, listings, and licenses to keep products on the U.S. market.

The role emphasizes thorough documentation, cross-functional collaboration, and compliance with FDA and ISO 13485 standards. The ideal candidate has a bachelor’s degree in a related field with 2+ years in a US FDA-regulated environment, strong technical writing, and