Regulatory Program Manager Jobs in Fox Lake, IL (NOW HIRING)

This is whereyour work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job-you will find purpose and pride.

Your Role at Baxter

This is where your work saves lives.

Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others' lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others.

The program manager will be responsible for leading infusion pump sustaining core team, by providing leadership and direction to assigned projects.

The core team leader is responsible for leading crossfunctional activities that support the lifecycle management, compliance, and continuous improvement of Baxter's infusion pump platforms postcommercialization. Operating at a Program Manager level, this role ensures sustained product performance, regulatory compliance, cost optimization, and timely execution of changes in a highly regulated medical device environment.

The role serves as the single point of accountability for sustaining projects, coordinating efforts across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Service, and Commercial organizations.

What you'll be doing

• Lead sustaining program for infusion pump products, including design changes, process improvements, supplier changes, and obsolescence mitigation within the Infusion Therapies and Technologies (ITT)

• Own the integrated project plan, schedule, scope, budget, and risk management for sustaining activities.

• Prioritize sustaining initiatives aligned with safety, compliance, business continuity, cost, and customer impact.

• Guarantee identification and communication of project risks, devise risk plans, and guide teams in the proactive handling of risk strategies.

• Communicate project status, risks, and mitigation plans to leadership and key stakeholders.

• Support long-term product roadmap planning, including end-of-life and transition strategies.

• Drive continuous improvement in sustaining processes, governance, and execution efficiency.

• Engage with external partners and vendors

What you'll bring

• Bachelor's Degree in Engineering field preferred with 8+ years total combined experience or Masters with 5+ years.

• 3+ years of experience in project management.

• Proven ability to drive cross-functional global teams within electromechanical medical devices

• PMP or equivalent project management certification

• Experience interfacing with global manufacturing, external vendors and supply chain organizations.

• Effective communication and presentation skills.

• Demonstrated self-starter who can quickly and efficiently manage continuous change; willing to challenge the norm when needed and drive decisions.

• Understanding and experience in good manufacturing procedures, good laboratory, and product development process requirements.

• Ability to collaborate within a distributed team to comprehend project requests and transform requirements into final project deliverables.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental 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 Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. 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 Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

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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.

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