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 don’t 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.

Essential Duties and Responsibilities:

As Product Design Owner, considered as the global representative of the given product line. As Technical 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 authority’s 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

• Represent as the single point of contact for all the CCB related activities and metrics for Renal Solutions Team at a global front

Qualifications

• Preferred Knowledge of Renal PD/HD/CRRT 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

• Ability to deliver results according to the plan

• Good communication

Key Skills and Experience

• Master’s in chemistry or M. Pharm. with at least 11 years of relevant experience or Ph.D. in relevant sciences discipline with at least 8 years of relevant experience.

• Excellent English verbal and written communication skills

• Exposure to medical devices and drug products

• Good knowledge of product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service

• Good knowledge of Design Control documentation and process

• Demonstrated project/program leadership in drug/pharmaceutical products

• Exposure to Product Risk Management for medical devices and drug productss

    Skills

Adequate orientation towards Renal PD therapies and products with time Good knowledge of product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service Good knowledge of Design Control documentation and process Working knowledge of international/regional/national regulations and standards Portfolio management and business acumen of PD products. Demonstrate project management skills in due time Ability to work independently. Can effectively communicate with internal and external customers. Demonstrates flexibility and the ability to shift gears between projects comfortably. Fluency in English Solid computer skills: email, documentation and collaboration tools: e.g. WebEx, Teams, Microsoft Office products, etc.

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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.