Regulatory Affairs Specialist – Intl. RA China

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 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

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

• Compile and follow-up 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 cross-functional teams
• Contribute to local or global projects as International Regulatory Affairs representative

• Technical degree or diploma in chemistry, biochemistry, biology or related
• Excellent English language skills (verbal and written)

• In Quality, Manufacturing, R&D, Regulatory or related areas.
• Min. 2-3 years background in IVD or Medical Device industry
• Regulatory and project management background desirable

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.

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