Senior Medical Device Labeling & Regulatory Compliance Consultant

Job SummarySeeking an experienced consultant to support a large-scale medical device labeling remediation program. This hands-on role involves authoring, reviewing, and updating Instructions for Use (IFUs), product labels, inserts, and user manuals to meet applicable regulatory and quality requirements.The consultant will independently identify labeling gaps, execute remediation activities, and maintain traceability between labeling content, design requirements, risk controls, and Design History File (DHF) records.Key ResponsibilitiesAuthor, review, and remediate IFUs, product labels, package inserts, user manuals, and related technical documentation.Perform labeling gap assessments against applicable FDA requirements, including 21 CFR Part 801 and Part 820, EU MDR, ISO 13485, and market-specific requirements.Develop and maintain traceability matrices connecting labeling content to design inputs, design outputs, risk management files, and DHF documentation.Support UDI, GS1, and barcode compliance.Manage labeling revisions through controlled QMS review, approval, and change-control workflows.Coordinate with Regulatory Affairs, Quality, Engineering, Manufacturing, and translation vendors to implement accurate global labeling updates.Maintain complete, traceable remediation records that support audits and documentation reviews.Required Qualifications10–12+ years of relevant experience in medical device labeling and/or regulatory compliance.Demonstrated hands-on experience authoring and reviewing medical device IFUs, labels, and user documentation.Experience executing labeling remediation for EU MDR transitions, acquisition integrations, or similar compliance programs.Strong knowledge of FDA labeling requirements, design controls, DHF documentation, and risk management.Experience linking labeling requirements and warnings to design documentation and risk controls.Ability to work independently, manage competing priorities, and collaborate across technical and quality teams.Strong technical writing, documentation review, and communication skills.Ability to work onsite in Boston, MA.Preferred QualificationsExperience with Class II and/or Class III medical devices.Knowledge of UDI, GS1, and barcode standards.Experience with BarTender, NiceLabel, or similar labeling systems.Familiarity with Agile, Windchill, Veeva, or comparable PLM/QMS platforms.Experience coordinating translations and country-specific labeling requirements.

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