Associate RA Specialist Russia/CIS

Support the administration of regulatory processes to obtain market authorization, registration and maintenance of certification of Radiology medical devices in Russia and CIS countries (Russia, Belarus, Kazakhstan, Kyrgyzstan, Armenia, Tajikistan, Turkmenistan, Uzbekistan, Mongolia, Azerbaijan, Georgia). Support EMEA regulatory hub in regulatory activities in the region.

TASKS AND RESPONSIBILITIES

• Support registration and maintenance of medical devices in Russia/CIS:
• Collection and execution of necessary documents for generating the dossier for medical devices and maintaining the licence in accordance with the requirements of the laws of the Russian Federation and CIS countries (including preparation of documents for technical, toxicological, clinical and other tests);
• Communication with laboratories (and eventually health authorities) as well as foreign suppliers for the purpose of obtaining document necessary to receive product licences in Russia/CIS
• Support implementation of the new regulation in Russia/CIS including interaction with the quality, PS, commercial, legal, R&D departments globally, regionally and locally for implementation of the local requirements for labeling of medical devices according to the new EUAE regulation
• Responsible for review of labeling and promotional material including translation in accordance with local regulations.
• Participate to RA EMEA hub team meetings, prioritization activities, process improvements, RA strategies and efforts within EMEA region.
• Support external distributors and OEMs for regulatory activities if needed.
• Support local commercial organization, marketing, legal, quality, product supply from regulatory stand point if needed
• Support global, regional and/or local projects for EMEA from regulatory standpoint, if needed.
• Support assessment needed by Global RA team (country regulations, project development, product change assessment etc )

Are you in for a new challenge in an innovative, digital environment? Would you like to work for a department that is very ambitious and wants to become the solution provider in Radiology?

Our business unit Radiology is part of our Pharmaceuticals division. At Bayer, we understand the importance of accurate diagnosis. By providing products and tools that help enhance medical images and increase diagnostic confidence, we make a strong impact on the field of Radiology. Let’s join our forces!

WHO YOU ARE

• Higher education
• Ability to work with large amounts of information
• Good communication skills (oral and written)
• Trust and emotional stability
• Analytical and constructive thinking
• Ability to set priorities, perseverance in achieving goals
• Ability to work in a team and comply with company processes in highly regulated environment
• Written and spoken English language proficiency advanced
• Written and spoken Russian language proficiency advanced is a plus
• Previous experience in quality or regulatory is a plus

WHAT WE OFFER

• An additional 8% holiday allowance, year-end premium, and a bonus (based on company results)
• 34 days of leave
• You have the option to work from home, but we expect you at least 2 days per week at the office.
• If you work from home, Bayer provides the required tools and a monthly internet allowance
• A solid retirement plan and bicycle lease plan
• An inspiring working environment with professional and committed colleagues
• A successful innovative organization with international career possibilities
• Challenges and possibilities to learn and to develop
• At Bayer, we value your well-being. We offer support via our employee assistance program and provide various tools and initiatives to enhance your well-being

For more information about the position, you can contact Nienke Klaar via Nienke.klaar.ext@bayer.com

We do not accept any unsolicited applications via agencies.  This vacancy is open to both internal and external candidates, internal candidates will be given priority in the recruitment process.

Division: Pharmaceuticals

Functional Area: Regulatory Affairs

Employment Type: Regular

Work Time: Fulltime

Job Segment: Medical Device, Regulatory Affairs, Compliance, Radiology, Work from Home, Healthcare, Legal, Contract