Research Associate III

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
Summary
Technical Owner of product design changes, worldwide registrations and launch activities within Sustaining Product Organization - Renal PD Solutions for dialysis treatment and intensive care
Essential Duties And Responsibilities

• As Tech Lead or Change Owner, define, organize, plan and execute activities related to product design change and new product registration in compliance with current international/regional/national regulations
• Provide technical assessment and strategy for product changes related to design, labeling, raw material, manufacturing support, regulatory compliance, quality improvement and new registrations in collaboration with senior scientists
• Coordinate and ensure follow-up of technical activities in collaboration with key stakeholders, with respect of project commitment, quality procedures and business needs
• Provide technical support to authorities questions in due time
• Propose options and develop action plan for problem-solving, product and process improvement
• Establish, maintain and update technical & Design documentation according to Good Documentation Practices

• Participate to multi-functional and international project team
• Ensure good internal and cross-functional communication and regular status update of activities
  

Qualifications

• Knowledge of Renal PD therapies and products
• Knowledge of product development stages, life cycle management and design control
• Working knowledge of international/regional/national regulations and standards
• Ability to work independently
• Ability to manage simultaneously several projects and shift priority according to needs
• Ability to solve problems, develop solutions, and make recommendations in collaboration with senior scientists

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  Ability to deliver results according to the plan
• Good communication
  

Key Skills And Experience

• MS in Chemistry, Pharmacy, Development Engineer or equivalent
• Min 5+ years of relevant experience in medical device and/or drug R&D
• Experience in coordination of technical projects
  

Reasonable Accommodation
Vantive 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. Form Link
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