Regulatory Affairs Specialist – FDA

This is a fully remote position, open to applicants in Oklahoma.

📋 Description

• Identify suitable U.S. regulatory pathways for IMMY’s in vitro diagnostic products, encompassing classification, product code selection, and predicate identification.

• Prepare and submit 510(k), PMA, De Novo, and Emergency Use Authorization submissions along with the necessary technical documentation.

• Oversee Q-Submissions and formal engagements with FDA review divisions.

• Monitor review timelines and address FDA inquiries.

• Provide guidance to product development teams regarding FDA expectations for analytical and clinical performance data, as well as verification and validation study design.

• Keep abreast of the U.S. regulatory status of marketed products and address registration, listing, licensing, or authorization concerns.

• Manage establishment registration, device listing, UDI/GUDID data, and other U.S. market-access registrations.

• Assist with post-market activities, such as reportability assessments, Medical Device Reports, field actions, and corrections and removals reports.

• Evaluate labeling, package inserts, instructions for use, and promotional and marketing materials for regulatory compliance.

• Maintain regulatory records, submission files, FDA correspondence, and other inspection-ready documentation.

• Support compliance with FDA medical device regulations, ISO 13485 requirements, and relevant laws, regulations, and standards.

• Stay updated on regulatory changes and execute necessary compliance adjustments.

⛳️ Requirements

• Bachelor’s degree in a related field.

• Over 2 years of experience in Regulatory Affairs support activities within a U.S. FDA regulated environment.

• Comprehensive understanding of U.S. FDA medical device regulations and their relevance to IVDs.

• In-depth knowledge of ISO 13485 standards requirements.

• Strong technical writing and verbal communication abilities.

• Highly organized with a keen attention to detail.

• Proficient in multi-tasking.

• Capacity to thrive in a fast-paced, deadline-oriented environment.

• Ability to work autonomously as well as collaboratively within a team.

• Skill in organizing information for clarity and ease of review, both internally and externally.

• Aptitude for identifying opportunities to enhance or streamline processes.

• Candidate must reside within the U.S.

• Successful completion of a comprehensive background check is required.

🏝️ Benefits

• Equal employment opportunity and nondiscrimination policy.

• Background check conducted in accordance with EEOC and FCRA regulations.

• Full-time employment.