Regulatory Affairs Manager - Labeling

The Regulatory Affairs (RA) Manager of Global Labeling Compliance leads the end-to-end alignment of medical device labeling, packaging, and digital assets with evolving international regulations. This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.

Position Overview

We are seeking a meticulous, strategic, and highly experienced Regulatory Affairs Manager to own and lead our Global Labeling Compliance program. This role is the central subject matter expert for all product labeling, including on-device labels, packaging, and Instructions for Use (IFU), ensuring full compliance with the complex and converging frameworks of global medical device and environmental regulations.

You will be responsible for the entire labeling lifecycle, from content development and strategy to final artwork approval and implementation. This position requires a deep understanding of how to translate intricate regulatory requirements from diverse global authorities (e.g., FDA, EU MDR) and environmental directives (e.g., WEEE, PPWR, REACH) into clear, accurate, and compliant labeling. You will serve as the critical link between our regulatory strategy, product development, and market-facing materials, mitigating risk and ensuring our products can be sold worldwide.

Key Responsibilities

This role is focused on the strategic and operational execution of global labeling compliance, requiring exceptional attention to detail and cross-functional leadership.

Global Labeling Strategy & Lifecycle Management

• Global Labeling Strategy: Develop, implement, and maintain a harmonized global labeling strategy that ensures consistency and compliance across all product lines and markets.

• End-to-End Process Ownership: Manage the entire labeling lifecycle, including the creation, review, approval, and maintenance of all labeling content and artwork within a controlled Quality Management System.

• Regulatory Intelligence for Labeling: Proactively monitor the global regulatory landscape for any new or revised labeling requirements. Interpret and assess the impact of changes from sources like the FDA, EU MDCG, and other competent authorities on product labeling.

Medical Device Labeling Compliance

• Core Regulatory Compliance: Ensure all product labeling strictly adheres to global medical device regulations, including FDA 21 CFR 801, EU MDR/IVDR General Safety and Performance Requirements (GSPRs Chapter III), and other key international standards.

• UDI and Device Identification: Lead and manage the implementation and maintenance of Unique Device Identification (UDI) requirements on all applicable label and packaging levels across global markets.

• Symbols and Content: Oversee the correct and consistent use of harmonized symbols (e.g., ISO 15223-1, ISO 7000), safety warnings, contraindications, and other required content on all labeling.

• Country-Specific Requirements: Manage all country-specific labeling requirements, including language translations, local health authority marks or logos, and specific formatting or content mandates.

Environmental & Sustainability Labeling Compliance

• Environmental Labeling Expertise: Act as the primary expert for all environmental and sustainability labeling requirements driven by global directives.

• Symbol and Mark Management: Ensure the correct application of environmental symbols and marks, including those for the WEEE Directive, battery directives (e.g., crossed-out wheeled bin), recycling (e.g., "Green Dot," Mobius loop), and packaging material identification.

• Substance-Driven Labeling: Manage all labeling requirements stemming from materials of concern (MOC) regulations. This includes ensuring necessary warnings or disclosures are present on labels or packaging as required by REACH, RoHS, California Proposition 65, and the EU MDR.

• Emerging Requirements: Stay ahead of and develop strategies for emerging environmental labeling trends, such as those related to the EU Packaging and Packaging Waste Regulation (PPWR), repairability scores, and the transition to electronic or digital labeling (eIFU).

Cross-Functional Collaboration & Process Ownership

• Internal Collaboration: Serve as a central hub for collaboration on all labeling matters.

  • Work with R&D, Packaging Engineering, and Supply Chain to ensure label content accurately reflects device specifications,