Specialist Regulatory Affairs (m/f)

Job description

JOB DESCRIPTION:

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 Diagnostics Division (ADD) is looking for a Regulatory Affairs Specialist (m/f) based in Wiesbaden.

Responsibilities

• Support all regulatory activities related to the site at Wiesbaden-Delkenheim.
• Closely collaborate with site operations to assure compliance of locally manufactured products to international regulations
• Establish and maintain relationship to TPM manufacturers and assure compliance to international regulations
• Build interface to Notified Body, assist in submissions and audits
• Conduct regulatory assessment of design changes and prepare notifications for worldwide submission
• Compile and submit documentation for Annex II product certification and re-certification
• Assist in creation and maintenance of Technical Documentation
• Support site related batch verification activities
• Back up procurement of site related legal documents and supply to the affiliates

Qualification

• Technical degree or diploma in chemistry, biochemistry, biology or related.
• Experience in Quality, Manufacturing, R&D, Regulatory or related areas.
• 2-3 years background in IVD industry desirable
• Fluent in German and excellent English language skills (verbal and written).

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 why candidates choose a career with Abbott in Germany.

AN EQUAL OPPORTUNITY EMPLOYER - Abbott welcomes and encourages diversity in our workforce.

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