Labeling Specialist
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Posted on:
21 hours ago
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1 Vacancy
Job Summary
Job Title
Labeling SpecialistJob Description
Labeling Specialist (IGTD Greater China Local Labeling Project)
In this role you have the opportunity to
Bring your passion and energy into a key local labeling initiative for Philips Image Guided Therapy (IGT) devices in Greater China dedicated to delivering high-quality Chinese product labeling and packaging in compliance with NMPA regulations GMPs FDA Regulations EUMDR ISO Requirements and Philips Standard Company Operating Procedures. This role will be the core local expert for Chinese labeling design and system review accelerating the local launch of IGT devices by eliminating reliance on sole headquarters support and ensuring alignment with Chinas regulatory and market needs..
You are responsible for
- Develop and maintain Chinese-language Instruction For Use (IFUs) documents product packaging labels and all associated labeling materials for IGTD Greater China products including layout design content localization product illustrations and copy adaptation in line with NMPA requirements.
- Utilize Philips global labeling templates and tools to create and revise Chinese labeling artwork and content adhering to corporate graphic standards brand guidelines and local regulatory compliance rules.
- Perform end-to-end quality checks and proofreading of Chinese labeling artwork and documents using measurement inspection tools (e.g. rulers barcode scanner) and related regulatory references adhering to a first-time right approach with zero critical errors for NMPA compliance.
- Conduct document control and review operations in Philips PLM (Windchill) system for all Chinese labeling deliverables including routing for internal approval revision control and proper storage of all local labeling materials.
- Collaborate closely with Greater China RA team to deep-dive into product specifications NMPA regulatory requirements and certification details ensuring all labeling content is fully compliant with local approval standards.
- Prepare and route Chinese labeling packages for first article inspection and internal QA/RA approvals and conduct prepress activities necessary to prepare labeling artwork files for accurate local production and labeling.
- Establish and cultivate a cross-functional local network (RA QA ISC local labeling team marketing) to facilitate the timely completion of Chinese labeling design review and production tasks.
- Support the Local Labeling Project Manager in coordinating with BU Labeling team R&D and global stakeholders on labeling template alignment global standard adherence and cross-regional labeling issue resolution.
- Maintain accurate records of all Chinese labeling deliverables revision history and compliance checks and update project management tools with real-time progress of local labeling tasks.
- Continuously monitor updates to NMPA labeling regulations and industry standards and provide local regulatory insights to both Greater China team and US headquarters to optimize global-local labeling synergy.
- Perform other labeling-related duties and special projects as assigned for the IGTD Greater China market
You are a part of
Philips IGTD Greater China team focused on accelerating the local launch of IGT devices and building an independent Chinese labeling capability for the region. You will collaborate closely with Philips Greater Chinas RA QA ISC and marketing teams and partner with the BU Labeling team R&D and five global Centers of Excellence (COEs: Regulatory & Clinical Affairs Supplier Quality Quality Management System Quality Assurance & Engineering Compliance & Audit). As a member of the local project team you are empowered to leverage your regulatory and labeling expertise to drive efficient local labeling delivery improve the speed of product market access in China and deliver tangible value to Philips Greater China health technology business. Additionally Philips believes people are #1 and fosters a culture of collaboration innovation and local empowerment for all team members.
To succeed in this role you should have the following skills and experience
- Bachelors degree or equivalent relevant experience in medical device regulatory affairs packaging/labeling design or a related field required.
- Proficient in Adobe Creative Suite (Illustrator InDesign Photoshop) and Microsoft Office Suite is a must.
- Experience with Adobe Lifecycle Bartender EnLabel and PLM systems (Windchill preferred) is a strong plus.
- In-depth knowledge of NMPA labeling regulations and requirements for medical devices is critical; familiarity with FDA EU MDR ISO standards is preferred.
- Hands-on experience in medical device labeling design localization or regulatory compliance in the Chinese market is highly desired.
- Excellent written and verbal communication skills in both Chinese and English (business fluent) with the ability to communicate technical and regulatory details with global and local stakeholders.
- Ability to exercise independent judgment consistent with Philips company policy and local regulatory requirements.
- Strong organizational skills with the ability to prioritize workflow and manage multiple labeling projects simultaneously for different IGT devices.
- Exceptional attention to detail and rigorous proofreading skills with a track record of delivering error-free regulatory documents/labeling materials.
- Ability to interact effectively with all levels of internal teams (RA QA ISC senior management) and external regulatory stakeholders as needed.
- Ability to adapt to changing regulatory processes and learn new labeling software/programs quickly.
- Strong problem-solving skills to identify labeling compliance issues and propose practical local solutions.
In return we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus we offer competitive health benefits a flexible work schedule and access to local well-being focused activities. Furthermore Philips University is available to all employees for learning and development opportunities.
This role offers you an opportunity to be a part a growing company and fantastic team passionate about developing novel medical device therapies to improve peoples live. Youll have opportunities to learn and contribute creative solutions.
Why should you join Philips
Working at Philips is more than a job. Its a calling to create a healthier society through meaningful work focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what its like working for Philips at a personal level visit the Working at Philips page on our career website where you can read stories from our employee blog. Once there you can also learn about our recruitment process or find answers to some of the frequently asked questions.
Required Experience:
IC
Key Skills
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
