Regulatory Affairs Specialist – FDA

IMMY•Norman, OK

3d•Remote

About The Position

The Regulatory Affairs Specialist – FDA is responsible for preparing and maintaining U.S. FDA regulatory submissions for IMMY's in vitro diagnostic products, and for securing and maintaining the clearances, registrations, listings, and licenses required to place and keep those products on the U.S. market.

Requirements

Bachelor’s degree in related discipline and 2+ years of experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment
Broad knowledge of U.S. FDA medical device regulations and their application to IVDs
Broad knowledge of ISO 13485 standards requirements
Effective technical writing and oral communication skills
Extremely organized with high attention to detail
Effective at multi-tasking
Ability to work in a fast-paced, timeline-driven environment
Ability to work independently and as part of a team
Ability to organize information so that it is easily understood and reviewed, both internally and externally
Ability to identify ways to improve/simplify processes

Responsibilities

Determine the appropriate U.S. regulatory pathway for IMMY’s products, including classification, product code selection, and predicate identification
Prepare and submit 510(k), PMA, De Novo, and Emergency Use Authorization submissions (as applicable), along with the technical documentation supporting each marketing authorization
Manage Q-Submissions and other formal interactions with FDA review divisions, including tracking review timelines and responding 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 the marketed portfolio on an ongoing basis to confirm that each product remains lawfully marketable, and identify and remediate any lapse or other issues with existing registrations, listings, licenses, or authorization.
Maintain establishment registration, device listing, UDI/GUDID data, and other institutional and/or product registrations related to U.S. market access.
Support post-market activities for marketed products, 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 that promotional, marketing, and sales-facing materials remain consistent with the cleared or authorized intended use
Maintain regulatory records, submission files, FDA correspondence, and other data and files inspection-ready for audit by FDA or other regulatory authorities or authorized third parties
Comply with, and assist IMMY in complying with, all applicable FDA medical device regulatory requirements, applicable ISO 13485 requirements, and all other applicable laws, regulations, and standards
Monitor and assess the operational impact of regulatory changes affecting IMMY’s processes and products available in the U.S., ensuring timely planning and implementation of any changes necessary for compliance