Remote FDA Regulatory Affairs Specialist (IVD)

IMMY; Norman (OK); Remote; USD 85.000 - 125.000; Vollzeit

Zusammenfassung

IMMY is seeking a Regulatory Affairs Specialist – FDA to prepare and maintain U.S. FDA submissions for in vitro diagnostic products and secure the necessary clearances, registrations, and licenses to place these products on the U.S.

market. The role involves determining regulatory pathways (510(k), PMA, De Novo, or EUA as applicable), coordinating submissions with FDA divisions, advising development teams, and ensuring ongoing compliance with FDA and ISO 13485 standards in a fast-paced

Qualifikationen

• Bachelor’s degree in related discipline and 3+ years of experience guiding U.S. regulatory submissions, including at least one 510(k)/De Novo/PMA submitted to FDA.
• 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.
• Ability to multitask in a fast-paced, timeline-driven environment.
• Ability to work independently and as part of a team.
• Ability to organize information clearly for internal and external review.
• Identify ways to improve/simplify processes.

Aufgaben

• 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 and remediate any lapse or issues with registrations, listings, licenses, or authorizations.
• Maintain establishment registration, device listing, UDI/GUDID data, and related registrations for U.S. market access.
• Support post-market activities for marketed products, including reportability assessments, Medical Device Reports, field actions, and corrections and removals.
• Review labeling, packaging, and materials for compliance with applicable regulations.
• Verify that promotional materials remain consistent with cleared/authorized uses.
• Maintain regulatory records, submission files, FDA correspondence, and audit-ready data.

Kenntnisse

Technical writing

Oral communication

Organizational skills

Multitasking

Independent worker

Team player

Attention to detail

Process improvement

Ausbildung

Bachelor’s degree in related discipline

Jobbeschreibung

IMMY is seeking a Regulatory Affairs Specialist – FDA to prepare and maintain U.S. FDA submissions for in vitro diagnostic products and secure the necessary clearances, registrations, and licenses to place these products on the U.S.

market. The role involves determining regulatory pathways (510(k), PMA, De Novo, or EUA as applicable), coordinating submissions with FDA divisions, advising development teams, and ensuring ongoing compliance with FDA and ISO 13485 standards in a fast-paced