Abbott Regulatory Affairs Manager Europe (m/f) 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 approximately 2,700 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. St. Jude Medical is now Abbott.

Abbott Point of Care (APOC) is looking for a Regulatory Affairs Manager Europe (m/f), based in Wiesbaden.

Responsibilities:

  • Independently develop regulatory strategies, plans and submissions for EU region.

  • Works with local distributors and / or affiliates to ensure timely preparation and management of submissions and approvals.

  • Provide updates on regulations and registration activities, and regulatory status.

  • Ensure regulatory compliance post market changes.

  • Familiar with the regulations & updates concerning In vitro diagnostics /medical devices.

  • May review and approve Advertising and Promotional Materials.

  • Reports to Divisional Director, Regulatory Affairs (Princeton, NJ USA)

Qualification:

  • BS/BA in life sciences or related discipline, or advanced degree, or equivalent combination of education and experience

  • Minimum 5 years of successful experience in Regulatory Affairs, preferably with a global manufacturer of medical devices, and successful performance of responsibilities presented above; experience in in vitro diagnostics highly preferred

  • Strong working knowledge of regional medical device regulations and requirements for submissions

  • Experience developing and executing strategy to successfully market medical devices

  • Experience with managing and preparing regulatory submissions.

  • Experience reviewing advertising/promotional materials

  • Demonstration of effective written and oral communication skills

  • Ability to manage multiple projects simultaneously

  • Fluent in English and German

  • Travel up to 20%

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.

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