Inion is looking for a Clinical Affairs Manager and a Regulatory Affairs Coordinator!
Inion Oy is a medical device company focused on the development and commercialization of innovative biodegradable and bioactive implants for Specialty Orthopaedics, Craniomaxillofacial and Spinal applications. Inion’s products have been in the global market for more than 20 years with good clinical history. Inion is a part of Naton Medical Group, a leading orthopedic company in China. Inion biodegradable implants are designed and manufactured in our Tampere facility which includes a state-of-the-art cleanroom and laboratory. Inion Oy has a subsidiary in the USA.
Post Market Surveillance Manager / Clinical Affairs Manager
You will be responsible for the continuous post market surveillance activities of Inion’s medical devices in accordance with the EU regulatory requirements, and thereby maintaining the post market technical files of the products. The work includes annual reporting, updates of clinical evaluation reports and risk management files, and managing post market clinical follow up studies together with Sales and Marketing team.
Suitable background is min. 3-5 years of work experience in the regulatory affairs of medical devices and academic degree of education. Knowledge of EU Medical Device Regulation will be helpful to quickly catch on to the tasks at hand. Knowledge of clinical study procedures and practicalities is an advantage. Fluent written and spoken English, and ability to create professional technical documents and reports in defined timelines is a requirement to succeed in this post.
We are looking for a person with internal motivation, initiative for problem solving, ability to complete tasks in time, and having interaction skills to coordinate tasks with colleagues. We offer you an interesting post to learn and develop your regulatory capabilities with Class III, IIa, Is/m/r medical devices as part of a highly professional and committed medical device team.
Regulatory Affairs Coordinator
You will be responsible for compiling and submitting regulatory application files for our product registrations in different international markets. You will also communicate with the external parties through the registration processes. Your tasks will also include translation management and proof check of instructions for use and product labels.
To succeed in this task you need to have fluent written and spoken English skills, and ability to compile professional application documents by utilizing the product technical files and modifying them according to the national requirements of the target market. Suitable background to support you in this task is experience in technical writing or other complex documentation work and academic degree of education. Prior experience in medical device regulatory affairs is a definite advantage.
We are looking for a person with internal motivation, efficiency, good eye in details as well as good interaction skills. The job typically includes several projects in parallel and bringing them into the finish in time. We offer you an interesting post to learn and develop your regulatory capabilities with Class III, IIa, Is/m/r medical devices as part of a highly professional and committed medical device team.
The application period for these positions is closed.