Regulatory Affairs Specialist - Wiesbaden, Deutschland - Abbott Laboratories

Abbott Laboratories

Geprüftes Unternehmen

Wiesbaden, Deutschland

vor 2 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 4,000 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.

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

The Opportunity
This position works out of our Wiesbaden Abbott B.V. location

Regulatory Affairs Specialist - Intl. RA China & Japan
Primary Function

Support registration activities in China & Japan related to the IVDR Program and other type of product registrations within International Regulatory Affairs

Major Responsibilities:

Compile and followup on documentation required for submission or closure of supplemental requests received from local agencies
Closely collaborate with legal and physical manufacturing sites as well as TPM partners and ensure compliance with IVDR and internal regulations
Work closely with IVDR Program contacts and Regulatory Teams in China & Japan
Support impact assess of design changes and change notifications
Assist in creation of technical documentation and explanation letters to local agencies
Anticipate potential issues and provide solutions
Act as regulatory representative in crossfunctional teams
Contribute to local or global projects as International Regulatory Affairs representative

Education: