Assoc. Mgr, Prod Surveillance

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary:

Associate Manager within the Post Market Surveillance (PMS) organization is responsible to supervise a dedicated team responsible for the handling of product quality complaints and the vigilance reporting following the applicable regulations and procedures. This role oversees the team’s operational activities and KPI’s. The function also supports the preparation and publication of EU MDR documents in the context of PMS.

Essential Duties and Responsibilities:

• Supervise and mentor a team responsible for efficient and effective product quality complaint handling.

• Manage vigilance reporting while ensuring timely and accurate submissions to Competent Authorities and notified bodies.

• Oversee & actively support the preparation and publication of EU MDR PMS documents, maintaining compliance with regulatory requirements.

• Collaborate with cross-functional teams to implement corrective and preventive actions when required.

• Collaborate with other functions (e.g. Patient Safety, Product Quality, Research & Development, Product Design Owner, Risk Team, etc) on product quality complaints related initiatives.

• Ensure team adherence to established processes and standards, continuously optimizing complaint handling and Vigilance procedures.

• Oversee and provide regular updates and reports on team performance and key metrics to management.

• Foster a culture of continuous improvement and innovation within the team.

• Perform Post Market Surveillance tasks as assigned by line manager.

Qualifications:

• A strong understanding of regulatory requirements, including EU MDR, related to Post Market Surveillance and Vigilance.

• Strong leadership and people management skills.

• Excellent communication and interpersonal skills.

•  Able to work in an environment that is highly regulated by procedures and quality systems.

• MS Office (Word, Excel, PowerPoint…).

Education and/or Experience:

• Minimum bachelor’s degree (Preferred: Life Sciences, Engineering or Quality Assurance).

• Minimum of 3-5 years of experience in people management and preferred relevant experience in Post Market Surveillance and Vigilance, with a focus on product quality complaint handling.

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.