Sr Product Labeling Graphic Designer (Remote)

📍 Job Overview

Job Title: Senior Product Labeling Graphic Designer
Company: Insulet Corporation
Location: United States (Remote)
Job Type: Full-Time
Category: Operations - Quality Assurance & Regulatory Compliance
Date Posted: December 12, 2025
Experience Level: 5-10 Years
Remote Status: Remote Solely

🚀 Role Summary

• This role is critical for ensuring the accuracy, quality, and regulatory compliance of all product labeling, art, and proofs for Insulet's medical devices.
• The position requires a Senior Graphic Designer with specialized experience in product labeling for regulated industries, particularly healthcare/life sciences.
• Key responsibilities involve managing the end-to-end process of product labeling design, from initial request to final implementation, including change control procedures.
• The role demands a strong understanding of regulatory requirements (FDA, UDI/GTIN) and the ability to translate complex technical and medical information into clear, compliant labeling.

📝 Enhancement Note: While the title is "Graphic Designer," the emphasis on "Product Labeling," "Quality Assurance," "Regulatory Requirements," "UDI/GTIN," and "Change Control" firmly places this role within the Operations domain, specifically intersecting with Quality Assurance and Regulatory Affairs. The "Sr." designation implies a need for independent project management and potentially mentorship.

📈 Primary Responsibilities

• Labeling Design & Development: Design, edit, and maintain product labels, packaging, User Guides (IFUs), Patient Guides, and other supporting product labeling documentation.
• Change Control Management: Support and implement the PCO/ECO (Change Control) process for all product labeling updates, ensuring seamless integration of changes.
• Regulatory Compliance: Ensure all labeling adheres to medical, legal, and regulatory requirements, with a strong understanding of FDA guidelines and UDI/GTIN standards.
• Technical Accuracy & Proofreading: Meticulously proofread all technical aspects of design and development projects for accuracy and consistency across all packaging and product labeling.
• Stakeholder Collaboration: Attend meetings with key stakeholders, including customers and cross-functional teams, to gather requirements and ensure successful completion of labeling requests.
• Vendor & Print Management: Define print specifications and liaise with print houses to ensure accurate and high-quality production of labeling materials.
• Content Management & Templates: Design, edit, and maintain labeling templates and content management systems to ensure brand consistency and efficiency.
• New Product Launch Support: Prepare new graphics, images, and supporting documentation for new product launches, ensuring timely delivery.
• Issue Resolution: Lead or support the resolution of any issues encountered during labeling development and production.
• Process Adherence: Ensure all work complies with Standard Operating Procedures (SOPs) and relevant regulatory guidelines.

📝 Enhancement Note: The responsibilities highlight a blend of creative design and rigorous operational execution, emphasizing process adherence, change management, and regulatory oversight, which are core to operations roles in regulated industries.

🎓 Skills & Qualifications

Education:

• Bachelor’s Degree required.

Experience:

• Minimum of 5-7 years of work experience specifically in Product Labeling.
• At least 3 years of experience managing product labeling projects independently.
• A minimum of 3 years of experience in Healthcare/Life Sciences product labeling is mandatory.
• Minimum of 1 year of experience working with UDI (Unique Device Identification) / GTIN (Global Trade Item Number) requirements.
• Vendor Management Experience is preferred.
• Experience with diabetes products is preferred but not required.

Required Skills:

• Regulatory Knowledge: Solid working knowledge of FDA labeling regulations and other applicable regulatory requirements.
• Graphic Design Software: Moderate to Expert proficiency with Adobe Creative Cloud, including InDesign, Illustrator, and Photoshop.
• Labeling Software: Ability to design on-demand product labeling with various labeling software preferred.
• Technical Design: Moderate to expert knowledge in developing artworks and graphics for regulated medical products.
• Document Management Systems: Experience with document management systems such as Agile PLM and SharePoint.
• Microsoft Office Suite: Proficiency in MS Office, including Outlook, Project, and Visio.
• Workflow Understanding: Knowledge of the entire labeling workflow, from creation to obsolescence.
• Communication: Excellent writing and communication skills for cross-functional collaboration and stakeholder interaction.
• Attention to Detail: Strong proofreading skills and meticulous attention to detail are paramount.
• Product Comprehension: Ability to understand and communicate technical and clinical aspects of the product.
• Teamwork & Influence: Team player capable of working with and influencing cross-functional project teams.
• Organizational Skills: Ability to multi-task, organize, judge priorities, and provide guidance to other team members.
• Compliance: Ability to comply with SOPs and regulatory guidelines.

Preferred Skills:

• Vendor Management Experience.
• Diabetes product experience.
• Experience with specific labeling software beyond Adobe Creative Cloud.

📝 Enhancement Note: The emphasis on regulatory knowledge, specific software proficiencies (Adobe Creative Suite, PLM systems), and experience within the healthcare/life sciences sector are critical operational requirements for this role. The "Sr." level indicates a need for independent project management and a comprehensive understanding of the labeling lifecycle.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Labeling Project Case Studies: Showcase at least 2-3 detailed case studies of product labeling projects managed independently, highlighting the scope, challenges, and outcomes.
• Regulatory Compliance Examples: Include examples demonstrating your understanding and application of FDA labeling regulations and UDI/GTIN requirements.
• Graphic Design Excellence: Present a range of high-quality design work for packaging, IFUs, and patient guides, demonstrating aesthetic appeal alongside technical accuracy.
• Process Improvement Demonstrations: If possible, include examples where you identified and implemented process improvements within the labeling workflow, such as template optimization or efficiency gains.
• System Proficiency Examples: Briefly describe your experience with Document Management Systems (e.g., Agile PLM, SharePoint) and how you utilized them in previous roles.

Process Documentation:

• Workflow Mapping: Be prepared to discuss your understanding of the labeling lifecycle from creation to obsolescence, including how you would document and optimize key stages.
• Change Control Documentation: Demonstrate familiarity with documenting and managing changes through PCO/ECO processes, highlighting the importance of traceability.
• Cross-functional Collaboration Protocols: Outline how you would establish and maintain clear communication and documentation protocols when collaborating with diverse teams (e.g., R&D, Marketing, Legal, QA).

📝 Enhancement Note: For a Senior role in a regulated environment, a portfolio isn't just about visual design; it must demonstrate operational rigor, process understanding, and regulatory awareness. The focus should be on the why and how behind the design, not just the final output.

💵 Compensation & Benefits

Salary Range:

• Estimated Annual Base Salary: $89,625.00 - $134,437.50 USD
• Note: Actual pay is dependent on skills, experience, and education. This range reflects typical compensation for a Senior Graphic Designer with specialized product labeling experience in the US healthcare industry, considering the specified experience level and location.

Benefits:

• Comprehensive Health Coverage: Medical, dental, and vision insurance.
• Retirement Savings: 401(k) plan with a company match.
• Work-Life Balance: Paid Time Off (PTO).
• Wellness Initiatives: Additional employee wellness programs.

Working Hours:

• Standard Work Week: Approximately 40 hours per week.
• Flexibility: While a standard schedule is expected, the remote nature may offer some flexibility in daily hours, provided all project deadlines and collaboration needs are met.

📝 Enhancement Note: The salary range provided is based on the information supplied in the job description for US-based positions. This range is competitive for a Senior Graphic Designer role with specialized regulatory and labeling experience in the medical device sector.

🎯 Team & Company Context

🏢 Company Culture

Industry: Medical Devices / Healthcare Technology. Insulet Corporation is a leader in innovative insulin delivery systems, specifically known for its Omnipod platform. This industry demands high standards of quality, regulatory adherence, and a commitment to patient well-being. Company Size: Insulet is a publicly traded company (NASDAQ: PODD) with a significant global presence, indicating a structured corporate environment with established processes and growth potential. Founded: Founded in 2000, Insulet has a history of innovation and growth in the diabetes management space.

Team Structure:

• Department: Quality Assurance, Product Labeling. This team likely operates within or closely collaborates with the Quality and Regulatory Affairs departments.
• Reporting: The Sr. Product Labeling Designer will likely report to a Product Labeling Manager or a similar lead within the QA/Regulatory structure.
• Collaboration: Expect close collaboration with R&D, Marketing, Legal, Regulatory Affairs, and external vendors (print houses, potentially labeling software providers).

Methodology:

• Quality-Centric: Operations within Insulet are heavily influenced by rigorous quality management systems (QMS) and regulatory compliance standards.
• Process-Driven: The emphasis on SOPs, change control (PCO/ECO), and structured workflows is paramount.
• Data-Informed: While this role is design-focused, decisions regarding labeling content and format are informed by regulatory data, clinical feedback, and user testing.
• Innovation: As a medical device company, there's an underlying drive for innovation, even within the constraints of regulatory requirements.

Company Website: https://insulet.com/

📝 Enhancement Note: Understanding Insulet's position as an innovative medical device company is key. The operations within such a company are inherently tied to stringent quality and regulatory frameworks, which will shape the day-to-day work and expectations for this role.

📈 Career & Growth Analysis

Operations Career Level: This is a Senior individual contributor role. It signifies a level of expertise and autonomy where the designer is expected to manage complex projects independently, possess deep knowledge of specific operational processes (labeling, change control), and potentially guide junior team members. Reporting Structure: The role reports into the Quality Assurance or Product Labeling department, indicating a focus on operational excellence and compliance rather than pure creative marketing. This structure ensures that labeling decisions align with regulatory and quality standards. Operations Impact: The Sr. Product Labeling Graphic Designer directly impacts Insulet's ability to bring compliant products to market. Accurate and compliant labeling is essential for regulatory approval, patient safety, and avoiding costly recalls or compliance issues. Their work is a critical component of the GTM (Go-To-Market) strategy for new products and updates.

Growth Opportunities:

• Specialization Advancement: Deepen expertise in specific areas of medical device labeling, regulatory affairs, or user experience design for technical documentation.
• Leadership Potential: Transition into a Product Labeling Managerial role, overseeing a team and strategic initiatives.
• Cross-Functional Mobility: Move into related operational roles within Quality Assurance, Regulatory Affairs, or Product Management, leveraging their deep understanding of product documentation and compliance.
• Process Improvement Leadership: Lead initiatives to optimize labeling workflows, implement new technologies, or enhance the change control process.

📝 Enhancement Note: This role offers a clear path for career progression within the specialized field of medical device operations and regulatory compliance. The "Sr." title suggests a foundation for future leadership or advanced technical roles.

🌐 Work Environment

Office Type: Fully Remote. This offers flexibility for employees to work from their home office. Office Location(s): Primarily based in the United States, with a headquarters in Massachusetts. Remote employees may be expected to align with US time zones for collaboration.

Workspace Context:

• Digital Collaboration: The work environment will be highly digital, relying on collaborative platforms, video conferencing, and cloud-based document sharing.
• Tools & Technology: Access to Insulet's standard suite of design, document management, and communication tools will be provided.
• Team Interaction: While remote, active participation in virtual team meetings, project discussions, and knowledge-sharing sessions will be crucial for successful collaboration.

Work Schedule:

• Standard Hours: Expected to maintain a standard 40-hour work week, aligning with US business hours for effective team and stakeholder collaboration.
• Flexibility: The remote nature may allow for some flexibility in daily start and end times, but consistent availability for critical meetings and project deadlines is essential.

📝 Enhancement Note: The remote nature requires strong self-discipline, proactive communication, and proficiency with remote collaboration tools. Ensuring alignment with US time zones is critical for seamless integration with the core team and stakeholders.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: HR or a recruiter will likely conduct an initial phone screen to assess basic qualifications, cultural fit, and salary expectations.
• Hiring Manager Interview: A discussion with the hiring manager, focusing on your experience with product labeling, regulatory compliance, and specific design skills.
• Technical/Portfolio Review: A dedicated session where you will present your portfolio, discuss your design process, and answer detailed questions about your experience with labeling projects, regulatory requirements, and software proficiency. Be prepared to walk through specific case studies.
• Cross-functional Interview(s): Interviews with key stakeholders from related departments (e.g., Regulatory Affairs, R&D, QA) to assess your ability to collaborate and understand technical requirements.
• Final Interview: Potentially with a senior leader or department head to finalize the decision.

Portfolio Review Tips:

• Curate Strategically: Select 3-5 of your strongest, most relevant projects. Prioritize those that showcase your work in regulated industries (healthcare/life sciences), demonstrate your understanding of FDA/UDI requirements, and highlight your ability to manage complex labeling projects.
• Tell a Story: For each project, clearly articulate the challenge, your role, the process you followed (including any change control aspects), the tools you used, and the positive outcomes achieved (e.g., regulatory approval, improved clarity, efficiency gains).
• Highlight Operational Skills: Beyond aesthetics, emphasize your attention to detail, proofreading capabilities, understanding of print specifications, and experience with document management systems.
• Demonstrate Regulatory Acumen: Be ready to discuss how you ensured compliance with specific regulations and how you translated technical information accurately.
• Prepare for Technical Questions: Anticipate questions about Adobe Creative Suite proficiency, experience with specific labeling software, and your approach to UDI/GTIN implementation.

Challenge Preparation:

• Design Exercise: You might be given a hypothetical product or a component of existing labeling to redesign or critique, focusing on clarity, compliance, and user experience.
• Process Scenario: You could be presented with a scenario involving a labeling change request and asked to outline your approach, including stakeholder communication, documentation, and risk assessment.
• Regulatory Quiz: Be prepared for questions testing your knowledge of key FDA labeling regulations.

📝 Enhancement Note: The interview process will heavily weigh your ability to demonstrate both creative design skills and a deep understanding of operational processes and regulatory compliance within the medical device context. Your portfolio is your primary tool to showcase this blend.

🛠 Tools & Technology Stack

Primary Design Tools:

• Adobe Creative Cloud: InDesign (essential for layout and text-heavy documents), Illustrator (for vector graphics, logos, icons), Photoshop (for image editing and manipulation).
• Labeling Software: Proficiency with specific on-demand labeling software may be preferred or required. Candidates should be ready to discuss any such experience.

Document & Content Management:

• Agile PLM: Experience with this Product Lifecycle Management system is highly preferred for managing product data and documentation.
• SharePoint: Experience with SharePoint for document storage, collaboration, and workflow management.
• Content Management Systems (CMS): Experience designing, editing, and maintaining content within CMS platforms relevant to labeling.

Productivity & Collaboration:

• Microsoft Office Suite: Outlook (email, calendaring), Project (project planning, scheduling), Visio (workflow diagrams, process mapping).
• Collaboration Platforms: Tools like Microsoft Teams, Slack, or similar for daily communication and team interaction.
• Digital Proofing Tools: Familiarity with tools used for collaborative review and annotation of designs.

📝 Enhancement Note: Strong proficiency in Adobe Creative Suite is a baseline. Expertise in PLM systems like Agile PLM and document management systems like SharePoint are critical operational tools for this role, indicating a need for strong data management and version control capabilities.

👥 Team Culture & Values

Operations Values:

• Quality & Compliance: A relentless commitment to accuracy, safety, and adherence to all regulatory standards is non-negotiable.
• Accuracy & Detail: Meticulous attention to detail in all aspects of work, from design to proofreading, is paramount.
• Collaboration & Teamwork: Ability to work effectively with diverse cross-functional teams, fostering open communication and mutual respect.
• Efficiency & Process Optimization: A drive to improve workflows, streamline processes, and leverage technology to enhance productivity and accuracy.
• Accountability: Taking ownership of projects and responsibilities, ensuring timely and high-quality delivery.

Collaboration Style:

• Cross-functional Integration: Expected to actively engage with R&D, QA, Regulatory Affairs, Marketing, and Legal to ensure labeling meets all requirements.
• Proactive Communication: Regularly update stakeholders on project status, potential issues, and required inputs.
• Feedback-Driven: Open to constructive feedback on designs and processes, using it to refine work and improve collaboration.
• Stakeholder Management: Skillful in managing expectations and influencing stakeholders to achieve compliant and effective labeling solutions.

📝 Enhancement Note: The culture emphasizes operational rigor, quality, and collaborative problem-solving, reflecting the critical nature of product labeling in a regulated industry.

⚡ Challenges & Growth Opportunities

Challenges:

• Balancing Creativity with Compliance: The primary challenge is to create visually appealing and user-friendly labels while strictly adhering to complex regulatory requirements and technical specifications.
• Managing Multiple Stakeholder Inputs: Synthesizing feedback and requirements from various departments (e.g., Legal, R&D, Marketing) into a cohesive and compliant design.
• Keeping Pace with Regulatory Changes: Staying updated on evolving FDA regulations and international standards that impact product labeling.
• Remote Collaboration Effectiveness: Ensuring seamless communication and project execution in a fully remote environment.
• Technical Complexity: Understanding and accurately representing complex medical and technical information in a clear, concise manner.

Learning & Development Opportunities:

• Regulatory Updates: Access to training or resources on the latest FDA labeling guidelines and international medical device regulations.
• Advanced Design Software Training: Opportunities to deepen expertise in Adobe Creative Suite or learn new design and labeling technologies.
• PLM/DMS System Mastery: Gaining advanced proficiency in Insulet's Product Lifecycle Management and Document Management Systems.
• Cross-functional Knowledge: Deepening understanding of R&D, manufacturing, and quality assurance processes to better inform labeling design.
• Project Management Skills: Developing stronger project management capabilities through independent handling of complex labeling initiatives.

📝 Enhancement Note: The challenges highlight the specialized nature of this role, requiring a unique blend of creative, technical, and operational skills within a highly regulated environment. Growth opportunities focus on deepening expertise in these specific areas.

💡 Interview Preparation

Strategy Questions:

• "Describe a time you had to balance conflicting requirements from different departments (e.g., marketing vs. regulatory) for a product label. How did you resolve it?"
  • Preparation: Prepare a STAR method response focusing on your process for identifying conflicts, communicating with stakeholders, finding compromises, and ensuring the final solution met all critical requirements, especially regulatory ones.
• "Walk me through your process for ensuring technical accuracy and regulatory compliance in product labeling."
  • Preparation: Detail your steps from receiving a brief to final approval, including proofreading techniques, use of reference materials, collaboration with subject matter experts, and understanding of change control workflows.
• "How do you approach designing for regulated medical devices, considering user needs, technical specifications, and branding?"
  • Preparation: Discuss your design philosophy, emphasizing how you integrate user-centricity with strict compliance. Highlight your ability to translate complex information into accessible formats.

Company & Culture Questions:

• "What do you know about Insulet and the Omnipod platform, and why are you interested in working in the medical device industry?"
  • Preparation: Research Insulet's mission, products, and recent news. Connect your passion for design and operations to their goal of improving lives.
• "How do you foster collaboration and communication in a remote work environment?"
  • Preparation: Provide specific examples of how you use communication tools, proactively engage with colleagues, and ensure alignment on projects when working remotely.
• "What are your thoughts on the importance of quality and compliance in product labeling?"
  • Preparation: Emphasize your understanding of the critical role labeling plays in patient safety, regulatory adherence, and brand reputation.

Portfolio Presentation Strategy:

• Focus on Impact: For each presented project, clearly articulate the business objective, your specific contribution, the operational challenges overcome (e.g., tight deadlines, complex regulatory inputs), and the measurable results or positive outcomes.
• Showcase Process: Don't just show final designs. Explain your design process, including how you incorporated feedback, managed versions, and ensured accuracy. Highlight your use of tools like Adobe Creative Cloud, Agile PLM, or SharePoint.
• Highlight Regulatory Understanding: Be prepared to discuss the specific regulatory considerations for each project (e.g., UDI placement, GHS symbols, language requirements).
• Quantify Where Possible: If you can, use metrics to demonstrate the success of your work (e.g., "reduced customer queries by X% due to clearer IFU," "ensured all labels met new FDA guidelines prior to launch date").

📝 Enhancement Note: Your interview preparation should heavily lean into demonstrating your operational understanding of regulated product labeling, not just your graphic design talent. Show that you are a reliable, detail-oriented professional who can navigate complex processes and compliance requirements.

📌 Application Steps

To apply for this Senior Product Labeling Graphic Designer position:

• Submit your application through the Insulet Careers site via the provided URL.
• Tailor Your Resume: Optimize your resume to highlight keywords from the job description, such as "Product Labeling," "FDA Labeling," "Regulatory Compliance," "Adobe Creative Cloud," "Agile PLM," "Change Control," "UDI/GTIN," and "Healthcare/Life Sciences." Quantify achievements where possible.
• Curate Your Portfolio: Select your most relevant work, focusing on case studies that demonstrate your ability to manage complex labeling projects, adhere to regulatory requirements, and utilize relevant design and document management tools. Ensure it's easily accessible online.
• Prepare for Portfolio Presentation: Practice walking through your portfolio, clearly articulating your process, challenges, and outcomes for each relevant project, emphasizing operational and compliance aspects.
• Research Insulet: Understand their products, mission, and values. Be ready to articulate why you are a good fit for their culture and this specific role within their Quality Assurance and Product Labeling departments.

⚠️ Important Notice: This enhanced job description includes AI-generated insights and operations industry-standard assumptions. All details should be verified directly with the hiring organization before making application decisions.

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