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Stellenbeschreibung

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional’s and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

THE OPPORTUNITY

This position works out of our site in Jena in the Abbott Rapid Diagnostics Division. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology.

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

WHAT YOU´LL DO

Prepare technical files and communications to be submitted to the Notified body, and regulatory agencies and manage execution of submission in alignment with regulatory plans
Support the regulatory department to ensure efficient and compliant business processes and environment in coordination with cross-functional teams
Assist with label development and review for compliance before release
Develop and maintain strong and effective relations with internal/external personnel.
Contribute to process / product improvement projects and risk management

REQUIRED QUALIFICATIONS AND SKILLS

Minimum of a bachelor’s degree (BA/BS) from an accredited University
Min. of 2-3 years of working experience in Regulatory Affairs role within a regulated industry (Medical Device/ IVD/ Pharma/GMP/Biotech)
Strong written and verbal communication skills, both in English and German

PREFERRED QUALIFICATIONS AND SKILLS

Basic understanding of IVD regulation
Experience in managing multiple projects and cross functional teams
Experience in generating quality documentation
Positive mindset with Can-do attitude
Ability to adapt quickly and effectively to shifting priorities
Very strong attention to detail
Teamwork enthusiast

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 fast-growing 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
Multi-national 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.

We ask for your understanding that we only consider online applications via our online application portal. Applications by email or post cannot be processed. Original documents will not be returned.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.