Regulatory Affairs Specialist – FDA

🕒 Outubro 30

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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👻 Score fantasma 10%

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• Aberta há 11 dias.
• As vagas desta empresa costumam ser preenchidas em 21 dias.
• Sem salário divulgado.

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IMMY

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 1979

🏥 Saúde

💼 Consultoria

🏭 Manufatura

Healthcare • Consulting • Manufacturing

A IMMY é uma empresa que expande suas capacidades de diagnóstico por meio da aquisição da OLM Diagnostics, focando em diagnósticos moleculares inovadores. Com forte ênfase em infecções fúngicas, a IMMY oferece uma gama de produtos, incluindo testes de fluxo lateral e ensaios de imunoadsorção enzimática para auxiliar no diagnóstico preciso e oportuno de várias doenças fúngicas. Comprometida em melhorar o atendimento ao paciente em todo o mundo, a IMMY aproveita mais de 40 anos de experiência na área para fornecer soluções de teste confiáveis a profissionais de saúde em mais de 80 países.

Descrição

• Determine appropriate U.S. regulatory pathways for IMMY’s in vitro diagnostic products • Prepare and submit 510(k), PMA, De Novo, and Emergency Use Authorization submissions, as applicable • Prepare technical documentation supporting marketing authorizations • Manage Q-Submissions and formal interactions with FDA review divisions • Track review timelines and respond to FDA requests • Advise product development teams on FDA expectations for analytical and clinical performance data • Support verification and validation study design • Monitor the U.S. regulatory status of marketed products • Identify and remediate lapses or issues with registrations, listings, licenses, or authorizations • Maintain establishment registration, device listing, UDI/GUDID data, and other U.S. registrations • Support post-market activities, including reportability assessments, Medical Device Reports, field actions, and corrections and removals reports • Review labeling, package inserts, instructions for use, and other materials for regulatory compliance • Verify promotional, marketing, and sales materials align with cleared or authorized intended use • Maintain regulatory records, submission files, FDA correspondence, and other inspection-ready records • Assist with compliance with FDA medical device regulations, ISO 13485 requirements, and applicable laws and standards • Monitor regulatory changes and implement necessary compliance updates

🎯 Requisitos

• Bachelor’s degree in a related discipline • 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 • Knowledge of preSTAR/eSTAR submission format • Broad knowledge of ISO 13485 standards requirements • Effective technical writing and oral communication skills • Extremely organized with high attention to detail • Effective at multitasking • Ability to work in a fast-paced, timeline-driven environment • Ability to work independently and as part of a team • Ability to organize information for internal and external review • Ability to identify ways to improve and simplify processes • Must live within the U.S. • Successful completion of a thorough background check

🏖️ Benefícios

• Equal employment opportunity for all employees and applicants • Background check conducted in compliance with EEOC, FCRA, and applicable laws

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