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Abbott Vigilance Officer (m/f/d) in Wiesbaden-Delkenheim, Germany

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

In Germany, Abbott has more than 3,000 employees working in manufacturing, research and development, logistics, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn and Witten. Alere in Cologne and Jena is now Abbott.

Abbott Diagnostics Division is looking for a Vigilance Officer (m/f/d) based in Wiesbaden.

The role is responsible for reporting of medical device incidents (MDI) and Field Safety Corrective Actions (FSCA) to competent authorities in European Economic Area (EEA) & Switzerland.

The vigilance officer supports activities as Legal Manufacturer (LM) and Authorized Representative (AR) in all vigilance related matters.

Responsibilities:

  • Vigilance Reports to be reviewed and send to Competent Authorities within EEA & Switzerland for ADD and AM products (IVD&MD) according to shared service agreements.

  • FSCA and Trend Reports to be compiled and/or reviewed based on Field action package/ information provided from manufacturer

  • MDI and FSCA Reports to be notified to Notified Body, as required

  • Requests from Competent Authorities to be reviewed and responses to be collected, consolidated and submitted according expected time line

  • Follow-up reports to be sent to Competent Authority (and Notified Body, if required) as requested or committed

  • Stay up to date on vigilance related regulation and guidelines applicable for EU and EEA countries & Switzerland.

Profile:

  • Solid scientific background (Degree in Medicine, Biology, Chemistry or Similar)

  • At least 2 years of experience in diagnostic and/or drug industry

  • Experience to work in an international work environment or on international projects is required; work experience in foreign country is welcome

  • Good English skills (experienced level required, negotiation level preferred); At least one more European language is preferred

  • Knowledge of PC- and internet based applications

  • Project Management Skills and Negotiation skills

  • Travel up to 5%

  • Cultural sensibility

  • Teamplayer

Abbott Germany has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company’s success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application.

Discover at http://bit.ly/workingatabbottgermany why candidates choose a career with Abbott in Germany.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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