Senior Regulatory Labeling Specialist

Key Responsibilities

Labeling & Instructions for Use (IFU) Development

• Lead or support the creation, drafting, and maintenance of Instructions for Use (IFU), product inserts, user manuals, and technical labeling in compliance with applicable standards (e.g., ISO 15223, EU MDR/IVDR, FDA labeling regulations).
• Collaborate with cross-functional teams (Product, Engineering, Clinical, and Medical Affairs) to translate technical specs into clear, accurate, and compliant end-user instructions.
• Write, copy edit, proofread documents related to the product development and ensure documentation reflects a consistent voice and style
• Manage labeling changes through the internal change control system, ensuring document version control and traceability, from development, release, and post-market.
• Coordinate localization, translation management, and proofing process for global IFUs and other labeling internally and with 3rd party vendors.
• Identify and implement new or improved tools, templates, documentation methods and procedures to maintain efficiency.

Marketing & Promotional Material Review

• Under the direction of Management, serve as a regulatory reviewer for marketing and clinical materials
• Evaluate advertising, commercial collateral, website copy, digital campaigns, and social media content to ensure claims are substantiated, fair-balanced, and aligned with approved product indications.
• Mitigate regulatory exposure by identifying off-label claims or unverified promotional statements and proposing compliant alternative wording.

Systems, IT, and Data Management

• Support software release process
• Utilize Electronic Document Management Systems (EDMS), Electronic Common Technical Document (eCTD) publishing tools, and Product Lifecycle Management (PLM) software (e.g., MasterControl, Veeva, Arena) to archive and manage regulatory assets.
• Maintain and populate internal and external regulatory databases, tracking systems, and global product registration databases (e.g., FDA GUDID, EUDAMED).
• Optimize workflows to enhance cross-departmental regulatory efficiency.

General Regulatory & Compliance Support

• Assist with compiling, formatting, and organizing regulatory submissions (e.g., 510(k), STED, CE mark technical files).
• Monitor changing regulatory requirements, guidance documents, and industry standards related to labeling and promotional activities.
• Assist in regulatory audits, inspections, and post-market compliance initiatives as required.

Qualifications & Requirements

• Education: Bachelor's degree in life sciences, technical field, or a related discipline.
• Experience: 5-7 years of experience as a technical writer
• Labeling Expertise: Proven experience drafting, updating, or reviewing technical documentation, labeling, or IFUs under regulatory frameworks (FDA, EU MDR, etc.).
• Marketing Review: Hands-on experience with marketing-material review processes and evaluating commercial marketing content against approved indications/claims.
• IT & Systems Proficiency: High computer literacy with demonstrated proficiency in EDMS, PLM systems, databases, advanced Excel/data tools, and document collaboration platforms (Veeva, MasterControl, SharePoint, TrackWise, etc.).
• Communication: Excellent written and verbal communication skills with a strong eye for detail, grammar, and technical drafting.
• Project Management: Ability to manage multiple review requests and projects simultaneously under firm commercial deadlines.

Preferred Qualifications

• Familiarity with XML, structured authoring tools, or translation management systems for global IFUs.
• Experience with UDI (Unique Device Identification) registration procedures (GUDID, EUDAMED).
• Experience with MadCap Flare is a plus.
• Hands-on experience with command-line tools, DOS/Batch scripting, and Java environments to support developer documentation and automated publishing build processes is a plus.

Pay and benefits

This position has an estimated base salary of $145,000 - $168,000, bonus, and equity. #LI-IB1

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