Regulatory Affairs Specialist – FDA

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

📋 Description

• Identify suitable 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 necessary.

• Develop technical documentation that supports marketing authorizations.

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

• Monitor review timelines and address FDA inquiries.

• Provide guidance to product development teams on FDA standards for analytical and clinical performance data.

• Assist in the design of verification and validation studies.

• Keep track of the U.S. regulatory status of marketed products.

• Identify and rectify any lapses or issues regarding 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.

• Ensure promotional, marketing, and sales materials are consistent with cleared or authorized intended use.

• Maintain regulatory records, submission files, FDA correspondence, and other documents that are ready for inspection.

• Assist in adhering to FDA medical device regulations, ISO 13485 requirements, and relevant laws and standards.

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

⛳️ Requirements

• Bachelor’s degree in a relevant field.

• Over 3 years of experience in guiding U.S. regulatory submissions.

• Have prepared and successfully submitted at least one 510(k), De Novo, or Premarket Approval request to the FDA.

• Extensive knowledge of U.S. FDA medical device regulations and their application to IVDs.

• Familiarity with preSTAR/eSTAR submission formats.

• Comprehensive understanding of ISO 13485 standards requirements.

• Strong technical writing and oral communication abilities.

• Highly organized with a keen attention to detail.

• Proficient in multitasking.

• Capable of thriving in a fast-paced, timeline-driven environment.

• Able to work independently as well as collaboratively within a team.

• Skilled in organizing information for both internal and external reviews.

• Competent in identifying ways to enhance and streamline processes.

• Must reside within the U.S.

• Completion of a comprehensive background check is required.

🏝️ Benefits

• Equal employment opportunity for all employees and applicants.

• Background check conducted in compliance with EEOC, FCRA, and applicable laws.