We are looking for a Regulatory Affairs Coordinator to join the team! In this position, you will be responsible for compiling and submitting international registration documents for new countries, products and distributors, and for the related correspondence during the registration processes. Your tasks will also include managing translations and proof check of product labeling. You will be part of the team who conducts adverse event reporting and other various tasks related to regulatory processes around the world.
Suitable background is preferably 2-3 years of work experience in the regulatory affairs of medical devices/technical writing and academic degree of education. Fluent written and spoken English and ability to create professional medical/ technical/ scientific documents and reports is a requirement. Knowledge of quality system and/or technical file requirements in the medical device sector are an advantage. Prior experience in translation procedures or use of M-Files will support the quick adaptation to work tasks.
Working at Inion
We provide a close view to the global commercialization of medical devices, and you will work with our team of 5 regulatory affairs experts in an open and friendly working culture. Our offices are located next to Tampere University Hospital and accessible by tram.
We are looking for a person with motivation for both simple projects and more complicated projects, who is also technically handy in compiling clear document submissions and sharing them in different platforms. The job typically includes several projects in parallel, which need to be completed in schedule.
The application period for this position is closed.