Regulatory Affairs Specialist – FDA

IMMY•Norman, OK

3d•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 required to place and keep those products on the U.S. market. The position is remote-eligible, but candidates must live within the United States. The role determines regulatory pathways and prepares applicable marketing authorization submissions, manages interactions with FDA, and advises product development teams on FDA expectations for performance data and study design. It also maintains marketed products’ U.S. regulatory status and registrations, supports post-market activities, reviews labeling and promotional materials, maintains inspection-ready regulatory records, and monitors regulatory changes. A senior designation may be considered 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 Pre Market 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 standards 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 can be easily understood and reviewed internally and externally.
Ability to identify ways to improve or simplify processes.
Must live within the United States.

Responsibilities

Determine appropriate U.S. regulatory pathways for products, including classification, product code selection, and predicate identification.
Prepare and submit 510(k), PMA, De Novo, and Emergency Use Authorization submissions, as applicable, 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, confirm they remain lawfully marketable, and identify and remediate lapses or other registration, listing, license, or authorization issues.
Maintain establishment registration, device listing, 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 regulatory compliance.
Verify promotional, marketing, and sales-facing materials are consistent with cleared or authorized intended use.
Maintain regulatory records, submission files, FDA correspondence, and other data and files in inspection-ready condition.
Comply with and assist IMMY in complying with applicable FDA medical device regulatory requirements, ISO 13485 requirements, and other applicable laws, regulations, and standards.
Monitor and assess the operational impact of regulatory changes affecting U.S. processes and products, and ensure timely planning and implementation of necessary compliance changes.