Medical Director, Device Vigilance

Medical Director, Device Vigilance

Baxter International

Warsaw, Poland

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.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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