Regulatory Product Data Steward

We are seeking a dedicated team of Regulatory Product Data Steward to support a major regulatory compliance initiative scheduled for completion by the end of this year. This team will be responsible for extracting, validating, and updating product data from source documentation (primarily IFUs) and ensuring accurate, timely updates across our internal Agile PLM system and the FDA GUDID database.

This work is high‑volume, detail‑oriented, and process‑driven, requiring strong discipline, accuracy, and familiarity with regulated product data environments.

Key Responsibilities

• Review and interpret IFUs (Instructions for Use) for 40,000 products.
• Follow step‑by‑step data extraction instructions to gather required product attributes.
• Validate extracted data for completeness, accuracy, and compliance with internal standards.
• Update Agile PLM with newly gathered or corrected product data.
• Coordinate with internal IT teams to ensure proper data upload, formatting, and system validation.
• Perform FDA GUDID submissions and updates, ensuring alignment with regulatory requirements.
• Maintain detailed logs of work completed, data sources, and exceptions.
• Escalate discrepancies, missing data, or unclear IFU content to internal SMEs.
• Meet aggressive timelines to support year‑end compliance deadlines.
• Ensure all work adheres to quality, documentation, and audit standards.

Required Skills & Qualifications

• Experience working with IFUs, product documentation, or regulated product data.
• Strong attention to detail and ability to follow highly structured instructions.
• Familiarity with Agile PLM or similar product lifecycle management systems.
• Understanding of FDA GUDID requirements and submission workflows (preferred).
• Ability to work efficiently with large volumes of data and repetitive tasks.
• Strong communication skills for coordinating with IT and compliance teams.
• Experience in medical device, pharma, or regulated manufacturing environments is a plus.
• Ability to meet tight deadlines and maintain high accuracy under pressure

ABOUT BRICKRED SYSTEMS

BrickRed Systems is a global leader in next-generation technology consulting and workforce solutions, specializing in delivering high-quality talent across digital, engineering, healthcare, analytics, finance, operations, and business transformation domains. With a strong emphasis on innovation, scalability, and client success, BrickRed Systems helps organizations solve complex business challenges by providing skilled professionals across strategy, technology, creative, and operational functions.

BrickRed Systems fosters a culture of continuous learning, collaboration, and excellence, enabling professionals to contribute to high-impact global initiatives while advancing their careers.