Regulatory Affairs Specialist – FDA

🔥 0 minutes ago

🌪️ Oklahoma – Remote

🌪️ Oklahoma – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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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, including classification, product code selection, and predicate identification • Prepare and submit 510(k), PMA, De Novo, and Emergency Use Authorization submissions with supporting technical documentation • 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 and verification and validation study design • Monitor the U.S. regulatory status of marketed products and remediate registration, listing, licensing, or authorization issues • Maintain establishment registration, device listing, UDI/GUDID data, and other U.S. market-access 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, promotional, marketing, and sales-facing materials for regulatory compliance • Maintain regulatory records, submission files, FDA correspondence, and other inspection-ready files • Assist with compliance with FDA medical device regulations, ISO 13485 requirements, and applicable laws, regulations, and standards • Monitor regulatory changes and implement necessary compliance changes

🎯 Requirements

• Bachelor’s degree in related discipline • 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 • Candidate must live within the U.S. • Successful completion of a thorough background check required

🏖️ Benefits

• Equal employment opportunity and nondiscrimination policy • Background check conducted in compliance with EEOC and FCRA regulations • Full-time employment