Regulatory Affairs Specialist - Wiesbaden, Deutschland - Abbott Laboratories

Abbott Laboratories

Geprüftes Unternehmen

Wiesbaden, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

In Germany, Abbott has more than 3,000 employees working in manufacturing, research and development, logistics, manufacturing, sales and marketing.

They are located at Abbott's German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn, Cologne, Jena and Hamburg.

The Abbott Diagnostics Division in Wiesbaden-Delkenheim is looking for a

Regulatory Affairs Specialist (M/F/d):

Your Responsibilities:

Support all regulatory activities related to the site
Closely collaborate with site operations to assure compliance of locally manufactured products 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 recertification
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
Establish and maintain relationship to TPM manufacturers and assure compliance to international regulations

Your Profile:

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

This position is limited for 2 years.

Working at Abbott**At Abbott, you can do work that matters and help people to live a healthier and full life, grow your career, and learn, be your true self.

You will have access to:

Career development with an international company where you can grow the career you dream of.
An attractive benefits package (e.g. attractive Abbott Pension Plan, a company bike, employee stock purchase program)
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
A challenging position in a fastgrowing crisis independent industry
To become part of a dynamic, highly educated, highly skilled, and motivated team
Flat hierarchies, open appreciative mentality, and efficient, constructive lines of communication
Multinational environment, where we foster the development of our talents within the enterprise

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.