We are seeking an experienced and detail-oriented Regulatory Product Data Steward – Team Lead to lead a team supporting a major regulatory compliance initiative scheduled for completion by the end of this year.

The Team Lead will be responsible for overseeing the extraction, validation, governance, and updating of product data from source documentation, primarily Instructions for Use (IFUs), while ensuring accurate and timely updates across the Agile PLM system and FDA GUDID database.

This role requires a strong understanding of regulated product data environments, excellent team leadership capabilities, and the ability to manage high-volume, deadline-driven data operations while maintaining strict quality and compliance standards.

The ideal candidate will have 8–10 years of relevant experience, preferably within the medical device, pharmaceutical, healthcare, or other regulated manufacturing environments. Key Responsibilities

Team Leadership & Delivery

Lead and manage a team of Regulatory Product Data Stewards responsible for high-volume product data activities.

Plan, distribute, and monitor daily/weekly workloads to ensure project milestones and year-end deadlines are achieved.

Establish productivity and quality expectations and continuously monitor team performance.

Conduct regular reviews of team output, identify bottlenecks, and implement corrective actions.

Provide coaching, training, and guidance to team members on regulatory data processes and documentation standards.

Act as the primary escalation point for complex data discrepancies, process issues, and operational challenges.

Regulatory Product Data Management

Oversee the review and interpretation of IFUs and other product documentation for approximately 40,000 products.

Ensure the team accurately extracts required product attributes by following defined data extraction guidelines.

Review and validate extracted data for completeness, accuracy, consistency, and regulatory compliance.

Oversee updates to Agile PLM and ensure product information is maintained accurately.

Coordinate with IT teams on data uploads, formatting, system issues, and validation activities.

Oversee FDA GUDID submissions and updates, ensuring data alignment with regulatory requirements.

Ensure consistency between source documentation, Agile PLM, GUDID, and internal product records.

Quality & Compliance





Define and monitor quality-control processes for product data extraction and updates.

Conduct sample audits and quality checks of team deliverables.

Identify recurring data-quality issues and implement process improvements.

Maintain detailed documentation of completed work, data sources, exceptions, corrections, and approvals.

Ensure all activities comply with internal quality procedures, documentation requirements, and audit standards.

Support audit readiness by ensuring complete and traceable documentation of regulatory data activities.

Stakeholder & Cross-Functional Coordination

Collaborate with Regulatory Affairs, Quality, IT, Product, Compliance, and other internal stakeholders.

Work closely with SMEs to resolve ambiguous, incomplete, or conflicting product information.

Communicate project status, risks, dependencies, and issues to management and stakeholders.

Coordinate with IT and system teams to resolve Agile PLM and data-upload issues.

Provide regular reporting on team productivity, quality, backlog, risks, and project progress.

Process Improvement & Reporting

Develop and maintain operational dashboards and reports covering productivity, quality, backlog, and completion status.

Analyze team and project data to identify trends, risks, and opportunities for improvement.

Standardize processes, documentation, and work instructions where required.

Identify opportunities to improve data extraction, validation, submission, and quality-control workflows.

Support management in forecasting resources and planning workloads to meet aggressive project timelines.

Required Skills & Qualifications

8–10 years of overall skilled experience, preferably in regulatory data management, product data management, medical devices, pharmaceuticals, healthcare, or regulated manufacturing.

Proven experience leading or managing a team in a data-intensive or regulatory environment.

Strong experience working with IFUs, product documentation, technical documentation, or regulated product data.

Strong understanding of structured data extraction, validation, data quality, and governance processes.





Hands-on experience with Agile PLM or similar Product Lifecycle Management systems.

Knowledge of FDA GUDID requirements, workflows, and submissions is highly preferred.

Experience managing large-scale product datasets and high-volume data operations.

Strong understanding of data quality, documentation, traceability, and audit requirements.

Excellent analytical and problem-solving skills.

Strong Excel/data analysis and reporting capabilities.

Excellent communication and stakeholder-management skills.

Ability to manage multiple priorities and deliver under aggressive timelines.

Strong attention to detail with a demonstrated ability to maintain high accuracy at scale.

Ability to identify process gaps and drive continuous improvement.

Preferred Qualifications

Experience in medical device regulatory affairs or product data management.

Experience working with FDA-regulated products and GUDID.

Experience with Agile PLM, Oracle, SAP, or similar enterprise product-data systems.

Experience managing teams of 10+ members or large-scale data operations.

Experience with data migration, data cleansing, master data management, or regulatory data remediation projects.

Familiarity with UDI (Unique Device Identification) concepts and medical device regulatory requirements.

Experience working with global or cross-functional teams.

Key Competencies

Team Leadership

Regulatory Data Management

Product Data Governance

Data Quality & Validation

FDA GUDID / UDI

Agile PLM

IFU & Technical Documentation Review

Process Improvement

Stakeholder Management

Project & Deadline Management

Reporting & Data Analysis

Quality & Compliance

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.

📌 Regulatory Product Data Steward- Team Lead (Hyderabad)
🏢 BrickRed Systems
📍 Hyderabad