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Associate - EMEA Post Market Surveillance

Req # JR - 171763 Location San Ġwann tal-Għargħar, San Ġwann, Malta Job Category Quality Date posted 05/14/2025
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Associate - EMEA Post Market Surveillance

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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

Post Market Surveillance i.e. monitoring the safety of products released on the Global market.

Manage product complaints per documented procedures

Assess regulatory reportability of received complaints

Coordination of complaint investigations and results with multiple stakeholders

Provide support in other Post Market Activities such as CERs, PMS Plans etc.

Essential Duties and Responsibilities.  

•    Gather complaint information from local organizations/complainants;
•    Assess complaint information to determine regulatory reportability; manage timeliness of Vigilance reporting and communication with authorities
•    Work with plant quality organizations, technical services and suppliers to coordinate complaint investigations;
•    Provide training to applicable stakeholders.
•    Identify and escalate safety issues to management;
•    Assure consistency of complaint records;
•    Prepare complaint closure responses;
•    Maintain compliance to regulations and procedures;
•    Create reports
•    Coordinate Competent Authority (CA) requests 
•    Initiating Nonconformance records
•    Work on Post Market Surveillance requirements as part of the EU Medical Device Regulations

  • Post Market Surveillance Plans;

  • Post Market Surveillance Reports;

  • Periodic Safety Update Reports (PSURs);

  • Clinical Evaluation Reports (CERs)

Qualifications.

  • Preferred Bachelor level degree or equivalent

  • Able to work in an environment that is highly regulated by procedures and quality system;

  • Good team-player but able to organize its own work with autonomy;

  • Good interpersonal/communication.

  • Critical thinking

  • Computer skills: Basic MS Office (Word, Excel, PowerPoint, Outlook)

  • Fluent in English at all levels (writing/reading or speaking)

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.

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Address

Explore this location Triq San Giljan
San Gwann
SGN3000
Malta Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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