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
.
- Solid 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

📌 Regulatory Product Data Steward (India)
🏢 BrickRed Systems
📍 India