Strategic Manufacturing Support RA Mountain Home

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Your Role

This is where your creativity addresses challenges

You are creative, detailed, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce phenomenal results. Supports new product development and lifecycle maintenance activities for projects and products that are manufactured by the facility.

Representing on site Global regulatory function focusing on the following areas:

• Supporting manufacturing projects in liaison with the plant Quality and Manufacturing organizations.
• Coordinating the Regulatory Affairs change control process in liaison with main functions at the facility.
• Providing on-site regulatory support for audits/inspections related to Establishment licensing or regional submissions and regulatory compliance of the facility with medical devices national and international legislation requirements.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What you'll be doing

• Preliminary regulatory assessment of product changes prior to change control.
• New products implementation at the facility.
• Provide product portfolio management access to the facility and share with facility organizations requirements that are applicable in exporting countries (target countries).
• RA support during audits carried out at the facility (related with national requirements and international requirements applicable in all target countries).
• Contribute to CAPA/NCR boards.
• Member of change control board or change control liaison person (connecting the facility with Global RA, GRA, R&D and any other external company’s organization).
• Collect and send Quality Systems related documents for GRA to renew certification granted by international Authorities. Support Local RA and/or GRA with requests for facility related documents.
• Review, support the preparation of facility related documents (STED supporting documents) to send to GRA for regulatory submissions. Site submission expert for responses to regulatory authority requests during regulatory filing reviews and on-site related CAPAs.
• Prepare, maintain, and update Site Master File regulatory sections.
• Plant Quality Management Review participation: bring new and/or change to country regulations, requirements, and compliance projects on going.
• Provide continuous regulatory awareness training to Quality and Manufacturing personnel of the facility.
• Support to validation activities: checking if requirements in all target countries are being met.
• Collaborate with GRAs and key partners at Segments, R&D and facility’s leadership.
• Support the implementation of new regulatory requirements at the facility.

What you'll bring

• Bachelor Degree in Chemistry, Biology or Engineering required
• Sound basis of Regulatory knowledge
• Manufacturing and quality process understanding
• Scientific Knowledge (international Medical Device and international standards)
• Ability to lead sophisticated projects and timelines in a matrix team environment
• Strong oral and written communication and presentation skills
• Proven interpersonal skills including significant negotiation skills
• Ability to independently identify compliance risks and call out when vital
• Lead and coach others

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of 80,000 to 120,000. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter 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 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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter 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 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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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.