Regulatory Affairs Specialist – FDA

🔥 20 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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This company has sponsored H1B visas in the past.

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IMMY

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1979

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

IMMY is a company that expands its diagnostic capabilities through the acquisition of OLM Diagnostics, focusing on innovative molecular diagnostics. With a strong emphasis on fungal infections, IMMY offers a range of products including lateral flow assays and enzyme immunoassays to aid in the accurate and timely diagnosis of various fungal diseases. Committed to improving patient care worldwide, IMMY leverages over 40 years of experience in the field to provide reliable testing solutions to healthcare professionals across more than 80 countries.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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

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