Research Associate II

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.

Your role:

This role is aligned within the Vantive kidney care Drug Products - Americas Solutions and Containers R&D Team reporting to the Sr. R&D Manager, Drug Products - Americas Solutions and Containers Team in the USA. As part of the Sustaining Product Organization team you will play a key role in defining, organizing, planning, and leading global multi-functional projects related to all the modalities of Kidney care (PD, HD, and Acute).  You will also work on new product development projects and innovative technologies supporting improving our products, therapies, and patient outcomes.

This position will work on projects mainly associated with Peritoneal Dialysis (PD) solution and container products and will be responsible for life cycle management.

What you'll be doing:

• Define, organize, plan, and execute activities related to product design change and new product registration in compliance with current international/regional/national regulations with the support of senior colleagues and team members

• 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

• Propose options and develop action plan for problem-solving, product and process improvement

• Coordinate and ensure follow-up of technical activities in collaboration with customers, partners, and team members, with respect to project dedication, quality procedures, and business needs

• Work with regulatory standards and quality management systems in the field of medical devices and related areas

• Provide technical support to authorities’ questions in due time with the support of senior colleagues and technical mentors

• Establish, maintain, and update technical & design documentation according to Good Documentation Practices

• Participate to multi-functional and international project team for effective collaboration and deliverables

• Ensure good internal and cross-functional communication and regular status update of activities

What you'll bring:

• Ph.D in Chemistry, Material Science, Materials Engineering, Polymer Chemistry, Polymer Engineering, Chemical Engineering, Biosciences, Biomedical Engineering, or related field (preferred) or Masters in the above fields (required)

• Minimum of 5 years of diverse industrial experience

• Experience with the drug product and/or medical device introduction and approval process

• Working knowledge of international/regional/national drug and medical device regulations and standards (e.g., USP and ISO)

• Knowledgeable with ICH, FDA, relevant cGxPs, ISO, and quality systems associated with pharmaceutical and medical devices development

• Understands the implications of raw material change in pharmaceutical and medical devices industries (product impact, process impact, regulatory implications, end user, sterilization, etc.)

• Strong data analysis and analytical skills

• Demonstrates flexibility and the ability to shift gears between projects comfortably.

Vantive is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated b