Job Description

Job Title Product Owner - IFU

Job title:
You are a part of the IFU team in System Development Cluster within the R&D Department of the Image Guided Therapy (IGT) Business within Philips Healthcare. This Business Unit is responsible for marketing, service, development, and manufacturing of IGT systems used in the area of cardiac or vascular medical diagnosis and treatment (e.g. balloon angioplasty and stent procedures). Customers are interventional specialists, in the cardiology and radiology domain operating in a wide variety of hospitals across the globe. The team you will be working in is a high-performance, culturally diverse team working in a dynamic environment. The team is approx. 10 persons working in the areas of Usability, Design Validation, Process Improvement, and Instructions for Use.
Your role:

• Regulatory Requirement Management for IFU: Develop and maintain a regulatory roadmap for IFUs based on upcoming requirements from global regulatory bodies. Assess the impact of new regulations on IFUs for the upcoming product portfolio and ensure timely compliance.
• Release Overview & Documentation Governance of IFU Deliverables: Manage release overviews for IFUs, Addendums, Quick Reference Cards (QRCs), Emergency Instruction Cards (EICs), and Leaflets. Track how updates to these documents affect released products and upcoming product launches.
• IFU Change Management: Maintain a comprehensive overview of IFU-related defects, including impacted products and associated documentation.
• IFU Process Expertise: Stay well-informed about IFU processes, workflows, and any changes to ensure alignment with organizational standards. Drive continuous improvement initiatives for IFU creation and maintenance processes.
• Cross-functional Collaboration: Work closely with Regulatory Affairs, System Design, Localization, and Quality teams to ensure accurate and compliant documentation.
• Planning the creation and delivery of all new and updated instructions for use (IFU) for IGT Systems
• Actively participate in project team meetings and estimating the relative size of tasks.
• Collaborate and communicate effectively with cross-functional teams including Localization, Product/Project Management, Engineering, Quality and Regulatory, to produce high-quality and accurate customer documentation that complies with regulatory requirements and standards.
• Draft Requirements and Specifications for IFU (Instruction for Use)
• Consult with SMEs to refine and improve drafts
• Hold design reviews to approve draft English IFUs
• Arrange translations/localization of those IFUs that are required to be published in non-English language
• Work with localization outsource partner
• Ensure localizations are certified by partner
• Release final IFU (Instructions For Use) versions as per IGT quality system.

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You're the right fit if: (4 x bullets max)

• Bachelor's degree in engineering with 7+ years of experience writing and producing technical documentation for products.
• Experience working in a Healthcare equipment industry and knowledge of applicable regulatory requirements towards "Instructions for Use".
• Experienced as Project Engineer with End-to-End technical ownership.
• Exceptional communication skills, with ability to research, interpret, analyze, and write by interpreting technical source information.
• Ability to prioritize work, balance multiple projects concurrently, and meet strict deadlines.
• Experienced in Windchill PLM application
• Knowledge and/or experience using Tridion Docs or ST4
• Experienced in XML based CCMS and with publishing to PDF and HTLM5
• Experience with or knowledge of localization and its process.

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company's facilities.
Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

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If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .
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Skills Required