Regulatory Affairs Associate

🔥 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%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Prepare IVD regulatory documents for submission to domestic and international regulatory agencies • Provide operational support for regulatory submission activities • Interact with regulatory bodies to complete product registrations • Review shipping restrictions in relation to product regulatory status • Work with Sales and Customer Service to ensure compliance • Monitor new and existing regulations affecting IMMY products and processes • Standardize regulatory operations and establish documented protocols • Maintain knowledge of submission requirements and processes across multiple jurisdictions • Prepare and maintain product technical documentation • Explain regulations, procedures, and policies to employees and stakeholders • Maintain data and files for future regulatory audits • Assist in reviewing labeling, promotional, legal, and technical documentation for compliance

🎯 Requirements

• Bachelor’s degree in a related discipline or combination of other education/job-related experience • 2+ years of Regulatory Affairs job experience required for Specialist categorization • Effective technical writing and oral communication skills • Strong organization and attention to detail • Ability to multitask • 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 or simplify processes • Familiarity with FDA, IVDD, IVDR, ISO 13485, GMP, and other major international regulatory requirements • Ability to read and interpret domestic and international IVD regulations • Experience in a regulated environment, preferably Medical Devices or IVDs • Experience with regulatory submissions, preferably Medical Devices or IVDs • Candidate must live within the United States

🏖️ Benefits

• Equal employment opportunity and anti-discrimination protections • Background check conducted in compliance with EEOC, FCRA, and applicable federal, state, and local laws