About This Role

The Manager of Labeling has a crucial role and is responsible for overseeing all aspects of labeling for medical device (hardware, software and SaMD) products. This position requires a balance of project management, technical proficiency, and regulatory compliance, ensuring the accurate and timely execution of labeling and packaging projects in alignment with company strategies and business objectives.

Key Responsibilities

• Team Management, Project Management and Execution: Manage Labeling function and resources, through direct supervision of Labeling team and indirect collaboration with Product Management, Regulatory, and Engineering. Manage and oversee all aspects of labeling and packaging projects, ensuring the correct, complete, and compliant execution of product labeling and packaging for global countries. Design and lead the end-to-end labeling process from concept to completion, addressing any problems or exceptions that arise.
• Regulatory Compliance: Develop and maintain labeling and packaging procedures that adhere to global requirements such as FDA, GMP, ISO, and other applicable standards and regulations (e.g. EU MDR). Review and approve labeling changes in Quality documentation system ensure label and packaging designs (e.g. artwork, labeling, symbols) meet industry regulatory requirements and oversee label team participation in change control processes. SME for labeling to support external and internal audits. Collaborate with RA to maintain up-to-date knowledge of regulatory changes affecting labeling.
• Cross-Functional Collaboration:  Provide guidance regards to labeling content requirement to the project teams throughout the product development or change process. Work closely with cross-functional teams to gather necessary information for labeling and packaging, ensuring projects meet customer needs and regulatory standards. Facilitate effective communication and collaboration with both internal and external stakeholders. Interface with manufacturing partners to translate requirements into labeling/packaging outputs.
• Vendor Management: Establishes and manages relationships with labeling vendors (e.g. translation partners, external consultants, graphic vendors, etc.) to ensure the effective implementation of labeling processes to meet business needs and regulatory requirements.
• Continuous Improvement: Identify and lead initiatives including tools and systems needed for continuous improvement in the labeling process through observation, measurement, and root cause analysis. Ownership of labeling and packaging SOPs. Obtain feedback from key stakeholders and implement changes to enhance efficiency and effectiveness.
• Documentation and Reporting: Exhibit a strong understanding of good documentation practices, maintaining accurate records and documentation related to labeling changes, approvals, and project progress. Generate reports to track projects and provide feedback to ensure accuracy and compliance.
• Quality Control and Assurance: Implement and assist in quality control checks of labels and packaging materials. Provide leadership in maintaining department activities in line with established SOPs, best practices, and GMPs.
• Additional Responsibilities: Perform additional duties or assignments including managing labeling team members as directed by management, demonstrating flexibility and adaptability in a dynamic work environment.

Skills and Qualifications:

• Bachelor’s degree and minimum 7 years’ experience in labeling and packaging in the medical device or pharmaceutical industry required; software as a medical device (SaMD) labeling experience strongly preferred.
• Proven experience in managing labeling and packaging professionals, and managing projects in the medical device industry required.
• Exceptional leadership and communication skills.
• Demonstrated competency in operating under 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, HIPAA and other medical device industry standards/regulations
• Understanding of global medical device labeling regulations (US, EU, LATAM, Asia Pacific, Middle East, etc.) preferred
• Excellent leadership, people management and organizational skills, capable of working on multiple projects.
• Exceptional communication skills, both verbal and written.
• Ability to lead and drive continuous improvements and change management initiatives.

What's In It For You

This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer:

• emotional health support for you and your loved ones
• legal / financial / identity theft/ pet and child referral assistance
• paid parental leave, paid holidays, travel assistance for personal trips and PTO!

iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of Linked In Learning classes and so much more! 

FLSA Status: Exempt

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