International reinforcement
Nadezda Ershova has been hired as manager of regulatory affairs and quality systems. She has a strong international expertise and understanding of the industry and bring valuable market experience to the company's international expansion.
Nadezda will manage Brighter’s documentation and quality system and keep the company’s regulatory contacts. She has a background as a molecular biologist, has experience from in vitro diagnostics industry, studied at Novosibirsk State University, Royal Institute of Technology and Stockholm School of Entreprenuership.
She comes from Academy Town, which is an informal name of Novosibirsk Scientific Centre, a small area with a strong scientific and technological infrastructure that is located 25km south of the center of Novosibirsk, one of the biggest Russian cities.
After graduating as a molecular biologist Nadezda worked with Medical Biological Union, Ltd. (MBU), a significant Russian manufacturer and supplier of in vitro diagnostic reagents and control materials. When she in 2004 joined MBU’s External Affairs department, which undertook the whole range of duties for the expansion of the company’s operations globally, the division was relatively new, and she, as a departments’ team member, contributed to development of the basics for these activities, including tools that are in use even nowadays: for example, she lead the preparation of technical files suitable for the global market, for the entire company’s product range. She has also participated in creation, maintenance and constant improvement of the company’s quality management system.
Working with international partners and customers has given her essential insights into the medical technology industry and its regulatory traditions in different regions of the World, including special requirements on certain markets of Middle East and Asia.
“Moreover, my experience in such fields as international marketing and customer support helps me to keep focus on the customer needs, which I think is a very important reference point, even if my responsibilities now belong to the ‘back office’”, said Nadezda Ershova.
Cooperation between Nadezda and Brighter began back in 2010 and initially she helped out with the development of small but necessary elements of the product’s identity such as the first versions of packaging and instruction manual. Further, in cooperation with Brighter, she has prepared her thesis for the master’s programme at the Royal Institute of Technology, with the topic: ”Medical device regulations as a source of industrial leadership: A comparative study of American and European regulatory approaches”.
"We are very pleased to have hired Nadezda and with her really gained a unique and broad international expertise in these areas for the company. Having both knowledge and practical experience from so many international markets will facilitate our global expansion.", said Truls Sjöstedt CEO
For further information please contact:
Truls Sjöstedt, CEO Brighter AB (publ)
Telephone: +46 709 73 46 00
Email: truls.sjostedt@brightercompany.com
About Brighter AB (publ)
Brighter One™ - the patented all-in-one device that replaces the five things millions of people with diabetes need to use multiple times every day to survive and feel well.
Brighter develops and commercializes innovative solutions for diabetes self-care.
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www.BrighterCompany.com/video
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