Senior Labeling / Regulatory Compliance Consultant

Job Title: Senior Labeling / Regulatory Compliance Consultant (Medical Device)

Company: United Pharma Technologies Inc

Location: Danvers, MA

Employment Type: Contract

Work Arrangement: Onsite – Remediation Environment

Experience: 10–12 Years

Job Responsibilities

• Develop, review, update, and remediate medical device labeling, including Instructions for Use (IFUs), product labels, package inserts, user manuals, and technical documentation.
• Ensure compliance with 21 CFR Part 801, 21 CFR Part 820, EU MDR, and ISO 13485 requirements.
• Conduct labeling gap assessments and support remediation activities across multiple product portfolios.
• Develop and maintain traceability matrices linking labeling requirements to design inputs, design outputs, risk management files, and Design History File (DHF) documentation.
• Support Unique Device Identification (UDI), GS1 standards, and barcoding requirements.
• Collaborate with Regulatory Affairs, Quality Assurance, Engineering, R&D, and Manufacturing teams to resolve labeling compliance gaps.
• Manage labeling change control activities and ensure compliance with Quality Management System (QMS) processes.
• Support global labeling requirements, translations, and market-specific regulatory requirements.
• Review existing labeling documentation, identify compliance gaps, and implement corrective updates.
• Maintain accurate documentation and traceability records for audits, regulatory inspections, and remediation deliverables.
• Independently execute remediation activities in a fast-paced, regulated medical device environment.

Required Qualifications

• 10–12 years of experience in medical device labeling, regulatory compliance, or a related field.
• Strong knowledge of 21 CFR Part 801, 21 CFR Part 820, design controls, and DHF documentation.
• Hands-on experience authoring, reviewing, and updating IFUs, product labels, package inserts, and other medical device labeling documentation.
• Experience supporting large-scale labeling remediation initiatives, EU MDR compliance projects, and acquisition integrations.
• Knowledge of risk management documentation and traceability between labeling, design requirements, and regulatory requirements.
• Experience with labeling change control and QMS processes.
• Ability to identify labeling compliance gaps, develop remediation plans, and independently execute updates.
• Strong technical writing, documentation, organizational, and problem-solving skills.
• Excellent communication and collaboration skills.
• Ability to work onsite in a fast-paced remediation environment.

Preferred Qualifications

• Experience with UDI, GS1 standards, and medical device barcoding.
• Experience with labeling software such as BarTender and NiceLabel.
• Experience with PLM/QMS systems such as Agile PLM, Windchill, and Veeva.
• Experience supporting Class II and/or Class III medical devices.
• Knowledge of global labeling regulations and market-specific requirements.
• Experience with translation management and multilingual labeling.
• Experience supporting regulatory audits, inspections, and quality remediation programs.

Pay Scale

Anticipated hourly pay range: $60 - 65/hr

Benefits

Employees hired into this position are eligible for the following benefits, subject to 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 is provided other than that required by applicable state and local laws.