Regulatory Affairs Specialist – FDA

IMMY•Norman, OK

2d•Remote

About The Position

The Regulatory Affairs Specialist – FDA prepares and maintains U.S. FDA regulatory submissions for IMMY’s in vitro diagnostic products and secures and maintains the clearances, registrations, listings, and licenses needed to place and keep those products on the U.S. market. The position is remote-eligible for candidates who live within the U.S. The role determines regulatory pathways for new products and prepares applicable marketing authorization submissions, including 510(k), PMA, De Novo, and Emergency Use Authorization submissions. It manages FDA interactions, advises product development teams on performance data and study design, and maintains U.S. regulatory status and registrations for marketed products. The specialist also supports post-market activities, reviews labeling and promotional materials, maintains inspection-ready records, assists with compliance with FDA medical device regulations and ISO 13485 requirements, and evaluates the impact of regulatory changes. The title may be adjusted to Senior for candidates with higher-level experience.

Requirements

Bachelor’s degree in a related discipline.
At least 3 years of experience guiding U.S. regulatory submissions.
Prepared and successfully submitted at least one 510(k), De Novo, or Premarket Approval request to FDA.
Broad knowledge of U.S. FDA medical device regulations and their application to IVDs, including preSTAR/eSTAR submission format.
Broad knowledge of ISO 13485 standard requirements.
Effective technical writing and oral communication skills.
Strong organization and attention to detail.
Ability to multitask and work in a fast-paced, timeline-driven environment.
Ability to work independently and as part of a team.
Ability to organize information so it is easily understood and reviewed internally and externally.

Responsibilities

Determine appropriate U.S. regulatory pathways for products, including classification, product code selection, and predicate identification.
Prepare and submit applicable 510(k), PMA, De Novo, and Emergency Use Authorization submissions and supporting technical documentation.
Manage Q-Submissions and other formal interactions with FDA review divisions, track review timelines, and respond to Agency requests.
Advise product development teams on FDA expectations for analytical and clinical performance data, including verification and validation study design.
Monitor the U.S. regulatory status of marketed products and identify and remediate issues with registrations, listings, licenses, or authorizations.
Maintain establishment registration, device listings, UDI/GUDID data, and other registrations related to U.S. market access.
Support post-market activities, including reportability assessments, Medical Device Reports, field actions, and reports of corrections and removals.
Review labeling, package inserts, instructions for use, and other materials for compliance with applicable regulations.
Verify promotional, marketing, and sales-facing materials are consistent with cleared or authorized intended uses.
Maintain regulatory records, submission files, FDA correspondence, and other files in inspection-ready condition.
Comply with and assist IMMY in complying with applicable FDA medical device regulations, ISO 13485 requirements, laws, regulations, and standards.
Monitor regulatory changes affecting U.S. products and processes, assess operational impact, and ensure timely planning and implementation of necessary compliance changes.
Identify opportunities to improve or simplify processes.