[Remote] Regulatory Compliance Consultant

Note: The job is a remote job and is open to candidates in USA. United Pharma Technologies Inc is seeking a Senior Labeling / Regulatory Compliance Consultant to support a large-scale remediation program in a regulated medical device environment. The role focuses on developing and remediating labeling, conducting compliance assessments, maintaining traceability, and managing labeling changes in alignment with regulatory and quality system requirements.

Responsibilities

• Develop, review, and remediate medical device labeling, including:
• Instructions for Use (IFUs)
• Product labels and inserts
• User manuals and technical documentation
• Ensure full compliance with:
• 21 CFR Part 801 (Labeling requirements)
• 21 CFR Part 820 (Design controls, QMS integration)
• Global regulations (e.g., EU MDR, ISO 13485)
• Perform labeling gap assessments and drive remediation across product portfolios
• Create and maintain traceability matrices linking labeling to:
• Design inputs and outputs
• Risk management files
• DHF documentation
• Support UDI and labeling compliance, including GS1/barcoding standards
• Collaborate cross-functionally with:
• Regulatory Affairs
• Quality Assurance
• Engineering / R&D
• Manufacturing
• Manage labeling change control and ensure alignment with QMS processes
• Support global labeling activities, including translations and market-specific requirements

Skills

• 10 – 12+ years of experience in medical device labeling and/or regulatory compliance
• Strong working knowledge of: 21 CFR Part 801 and Part 820 Design controls and DHF documentation
• Proven experience: Authoring and reviewing IFUs, labels, and labeling documentation Supporting labeling remediation initiatives (e.g., EU MDR, acquisition integrations)
• Demonstrated ability to work hands-on in a remediation environment with minimal oversight
• Highly detail-oriented with strong documentation skills
• Able to operate independently while collaborating across teams
• Strong communicator across Regulatory, Quality, and Engineering functions
• Experience with: UDI, GS1, and labeling systems (BarTender, NiceLabel, etc.) PLM/QMS systems (Agile, Windchill, Veeva, etc.)
• Background supporting Class II and/or Class III medical devices
• Experience with translation management and global regulatory requirements

Benefits

• Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
• A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Company Overview

Company H1B Sponsorship