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.
This role is aligned within the kidney care Drug Products – Solutions and Containers R&D Team reporting to the Sr. Manager, Solutions and Containers 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 Kidney care modalities (PD, HD, and Acute).
This position will work on projects mainly associated with HD (hemodialysis) solutions and containers products and will be responsible for life cycle management.
What you will be doing:
- Responsible for defining, prioritizing, planning, and leading projects that are technically complex and multi-functional in nature related to new product registration and product design changes in compliance with current international/regional/national regulations.
- Coordinate with multi-functional project teams for effective collaboration and deliverables.
- Support product lifecycle management and Sustenance organization in the area of medical devices and drug products.
- Provide technical assessment and strategy for product changes related to design, labeling, legal entity, raw material, manufacturing support, regulatory compliance, quality improvement, and new registrations.
- Define, organize, plan, and execute activities related to product design changes and new product registration in compliance with current international/regional/national regulations with the support of senior colleagues and team members.
- Work with regulatory standards and quality management systems in the field of medical devices and related areas.
- Establish, maintain, and update technical & design documentation according to Good Documentation Practices.
- Actively participate in audits as needed.
- Provide technical support to authority questions in due time.
- Work with international/regional/national regulations and standards for drugs and medical devices.
- 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.
What you will bring:
- PhD (preferred) or Masters (required) in Pharmaceutical Sciences, Biomedical Engineering, Materials Science or Engineering, Chemistry, Chemical Engineering, or related science or engineering field.
- Minimum of 7 years of diverse industrial experience in given technical domains.
- Broad understanding of the overall product and therapy along with deep technical expertise in one or more fields related to drugs, drug products, and/or medical devices.
- Understanding of Design Control documentation.
- Demonstrated success with program and program management.
- Understanding of change controls and change processes.
- Experience with handling NCR, CAPA, and other quality management systems.
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 base salary for this position is $104,000 - 130,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
US Benefits at Vantive
This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental, and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.
We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Vantive’s US Benefits, please speak with your recruiter or visit our Benefits site:Benefits | Vantive
Equal Employment Opportunity
Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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 ourRecruitment Fraud Notice.
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