Manager, PMS - EMEA

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.

Essential Duties and Responsibilities:

• Manage, develop, train and coach the team members (remote) for efficient and effective product quality complaint handling (end-to-end processing of complaints) and vigilance reporting while ensuring timely and accurate submissions to Competent Authorities and notified bodies.
• Manage and oversee the training requirements for the team
• Ensure team adherence to established processes and standards, continuously optimizing complaint handling and Vigilance procedures.
• Perform daily governance 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.
• Oversee the management of the shared email boxes and the complaint samples shipment
• Gives input into the assessment of resources for the PMS team.
• Escalate product quality issues, signals, as appropriate to the necessary functions for consideration of corrective and/ containment actions.
• Participating in resolution of escalated issues and risks leading and/or participating in cross functional (including multiple site and Technical Services) continuous improvement activities and projects, including NCRs/CAPAs.
• Act as SME in internal/external audits related to PMS
• Oversee the process to answer questions from the competent authorities/Notified Bodies in the context of complaints and Vigilance activities in EMEA
• Support the PMS activities to take place according to the respective EU MDR regulations and in context of PMS and vigilance

Qualifications

• Must be fluent in English language; Other language(s) is a plus
• Strong written and oral communications skill
• Strong people management skills
• Strong understanding of international medical device regulations
• Strong critical thinking skills
• Strong presentations skills
• Comfortable working in a cross-functional, multicultural, international and regulatory environment

Education and/or Experience:

• Minimum a bachelor’s degree (life sciences preferred) or clinical certification or equivalent experience (defined as a minimum of 5 years of medical products industry experience),
• 5-7 years relevant work experience in cGMP related industry and leading a team

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

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