Product Design Owner - Clinical Nutrition

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

We are seeking a dedicated and experienced Product Design Owner for Clinical Nutrition On Market Finished Products to join our team in Braine L'Alleud. In this role, you will be responsible for supporting Supplier Notice of Change (SNCs), market enhancements, and operational improvements associated with the product family. Your expertise will ensure the quality and compliance of our clinical nutrition products, driving patient safety and regulatory adherence.

What you'll do

• Change Management and Enhancements:

Support Supplier Notice of Change (SNCs), market enhancements, and operational improvements.

Evaluate the design impact of changes and ensure compliance with regulatory standards.

• Documentation and Quality Assurance:

Maintain up-to-date documentation associated with the product family, including DHF Index and QTPP.

Conduct annual reviews of key quality indicators and update the DHF index accordingly.

• Change Approval and Compliance:

Approve moderate and major changes related to SNCs, product/process/cost improvements, and identify necessary results.

Monitor compliance with design/development and change control procedures.

Approve risk-related decisions in quality system processes and manage obsolete living deliverables upon product discontinuation.

• Technical Leadership and Collaboration:

Lead or provide technical expertise for projects related to patient safety, quality compliance, quality improvement, supplier changes, and regulatory compliance.

Collaborate with cross-functional teams, including R&D, regulatory affairs, quality, manufacturing, marketing, and medical/clinical affairs.

Provide technical support to project teams and participate in development and improvement activities associated with Chemistry, Manufacturing, and Controls (CMC).

• Regulatory Adherence:

Demonstrate a thorough understanding of and adherence to governmental and international industry requirements, procedures, regulations, and standards.

Ensure that appropriate requirements are met during sustaining efforts and new product development.

What you'll bring

• B.Sc. in a scientific field with 10+ years experience, M.Sc. with 5+ years experience or PhD with 1+ year of relevant experience in durg and/or medical device R&D
• Formulation development
• Good knowledge of product development stages and LifeCycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service.
• Good knowledge of Design Control Documentation and processes, ability to assess risks and mitigate
• Must be able to carry out strategy and vision set by the upper management and be able to communicate the vision to junior associates
• Experience in technical study design and implementation
• Ability to interpret results from sophisticated instrumentations and scientific studies and present conclusion to projet leader and senior management
• Write comprehensive technical documentation in English
• Basic project management skills
• Very good level of written and spoken English

What are some of the benefits of working at Baxter Healthcare Corporation?

We offer a driven total compensation package, with professional development opportunities, where a high importance is placed on work-life balance!

Join us in making a significant impact on the quality and safety of our clinical nutrition products!

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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