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Medical Director, Device Vigilance

Req # JR - 049638 Location Warsaw, Mazovia, Poland Job Category Patient Safety Date posted 11/09/2021

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.

Ensure user and patient safety of medical devices for Baxter Healthcare across all GBUs and Therapeutic Areas. Represent Medical Device Vigilance and provide expertise in the development of processes and procedures in which Medical Device Vigilance interfaces including Quality, Regulatory, Global Pharmacovigilance and Clinical/Medical Affairs functions. Provide medical oversight and management to the nurses within GPS. Serve as a medical resource in support of any field surveillance activity for internal and external customers.

Essential Duties and Responsibilities

  • Medical support for AE review of complaints

  • Medical support for AEs in Baxter studies

  • Support for Clinical Evaluation Reports

  • Signal management for device AEs

  • Field Surveillance Activities to support investigations and/or field actions including Health Hazard Analysis

Qualifications 

  • In-depth knowledge of medical device adverse event processing including triage, investigation, medical assessment and submission to regulatory authorities.

  • Knowledge and understanding of medical device regulations and regulatory guidelines and/or guidances.

  • Awareness, and preferably working knowledge, of coding dictionaries (e.g., MedDRA)

  • Excellent analytical and problem solving skills

  • Excellent oral and written communication and interpersonal skills

  • Ability to adapt and drive constant change for continuous improvement

  • Experience working in a team environment

  • Good Communication skills, collaboration and team work

Education and/or Experience

  • M.D. degree required with clinical experience.

  • At least 5 years of medical professional experience, including 1-2 years related clinical or regulatory experience in the medical device industry preferred.

  • Experience with multicultural teams, able to manage multiple tasks, and ability to influence in cross-functional team setting.

  • Knowledge and understanding of national and international medical device regulations and regulatory guidelines a plus

  • Working relationships with and exposure to various Regulatory Authorities worldwide

  • Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-marketing safety practice

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] 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.

049638

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