Associate - EMEA Post Market 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

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.