Abbott Regulatory Affairs Specialist, Russia / CIS in Hesse, Germany

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/St. Jude Medical is currently looking for a

Junior Regulatory Affairs Specialist, Russia / CIS (m/f)

based in Eschborn (next to Frankfurt/Main Germany)

Job summary:

Working under supervision, provide regulatory team’s support by preparation of pre-market approval of medical devices in the Russian Federation/ CIS countries region including response to questions from the local Competent Authorities concerning submitted registration files. This is performed ensuring products and procedures comply with the local regulatory requirements and standards. Supports necessary regulatory activities required for timely market entry.

Your role:

  • Prepares robust regulatory applications (for regulatory agencies in Russia / CIS) to achieve departmental and organizational objectives.

  • Maintains knowledge of pertinent medical device regulations in Russia / CIS Region to ensure submission requirements are current, up-to-date and are communicated to business unit colleagues. Ensures that information of such regulations and requirements, inlcuding labelling and language requirments, especially those that are new or modified, are communicated to appropriate personnel.

  • Support all company initiatives as identified by management and in support of Quality Management Systems (QMS).

  • Performs other related duties and responsibilities, on occasion, as assigned.

Your profile:

  • Educated to degree level, preferably within a scientific area (e.g. engineering, biomedical engineering).

  • Knowledge and experience of working in a regulated environment is required, and preferably in the medical devices/healthcare sector.

  • Proficient in operating a personal computer and in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software.

  • Experience with Databases is desired.

  • Russian - Native Speaker; The ability to read, write, and communicate effectively in Russian is required

  • The ability to read, write, and communicate effectively in English is also required.

  • Able to travel min 15%

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

JOB FAMILY:

Regulatory Operations

DIVISION:

ASJM Abbott St. Jude Medical

LOCATION:

Germany > Hesse : Helfmann - Park 7

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 15 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Follow Us:

Facebook at https://www.facebook.com/AbbottCareers

LinkedIn at https://www.linkedin.com/company/abbott-

YouTube at https://www.youtube.com/c/abbott

Twitter at https://twitter.com/AbbottNews