Senior Labeling / Regulatory Compliance Consultant – Medical Devices

Job Title: Senior Labeling / Regulatory Compliance Consultant Medical Devices
Location: Massachusetts Onsite
Pay Rate: $55/hr - $65/hr on W2
Experience: 10 12+ years
Company: Intellectt Inc

Job Summary:
Seeking a Senior Labeling / Regulatory Compliance Consultant to support a large-scale medical device remediation program. This hands-on role focuses on updating and reviewing Instructions for Use (IFUs), product labels, inserts, and user manuals while maintaining traceability to design controls, risk management, and regulatory requirements.

The consultant must independently assess labeling gaps, execute remediation activities, and coordinate changes across Regulatory Affairs, Quality, Engineering, and Manufacturing.

Key Responsibilities:

• Develop, review, update, and remediate medical device IFUs, product labels, package inserts, user manuals, and related technical documentation.
• Assess labeling against applicable FDA labeling and quality system requirements, EU MDR, ISO 13485, and market-specific requirements.
• Perform labeling gap assessments and drive corrective updates across product portfolios.
• Create and maintain traceability matrices linking labeling content to design inputs, design outputs, risk management files, and Design History File (DHF) documentation.
• Support Unique Device Identification (UDI), GS1, and barcode compliance activities.
• Manage labeling changes through established document control and QMS approval processes.
• Collaborate with Regulatory Affairs, Quality Assurance, Engineering/R&D, and Manufacturing to ensure labeling accuracy and consistency.
• Coordinate translations and global labeling updates to meet country-specific requirements.
• Maintain complete, accurate, and review-ready remediation records.

Required Qualifications:

• 10 12+ years of experience in medical device labeling and/or regulatory compliance.
• Strong working knowledge of 21 CFR Part 801, applicable 21 CFR Part 820 requirements, design controls, and DHF documentation.
• Proven hands-on experience authoring and reviewing IFUs, product labels, and related labeling documentation.
• Experience supporting labeling remediation programs, such as EU MDR transitions or acquisition integrations.
• Ability to connect labeling requirements with design documentation, risk controls, and regulatory commitments.
• Ability to execute remediation activities independently with minimal oversight.
• Strong technical writing, organizational, communication, and cross-functional collaboration skills.

Preferred Qualifications:

• Experience supporting Class II and/or Class III medical devices.
• Knowledge of UDI, GS1, and barcode standards.
• Experience with labeling systems such as BarTender or NiceLabel.
• Familiarity with PLM/QMS platforms such as Agile, Windchill, or Veeva.
• Experience managing translations and market-specific labeling requirements.
• Familiarity with EU MDR and ISO 13485.

Contact to Apply:
Name: Uzma Kousar Mohammed
Email:

uzma.kousar@intellectt.com

Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:
Health Insurance: 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.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.