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. Our company’s core expertise is commercialization of biodegradable implants made from its proprietary Inion® family of biomaterials. Our focus is to provide complete solutions for target surgical procedures. Inion was founded in Finland 20 years ago and is now a part of Naton Medical Group, a leading orthopedic company in China. Inion biodegradable implants are designed and manufactured in state of the art product development and clean room production facilities in Tampere. Inion Oy has a subsidiary in the USA.
We are looking for a
SENIOR REGULATORY AFFAIRS MANAGER
to continue the transition of our legacy products to the EU MDR requirements, and maintain the compliance to EU regulations after transition.
Your main responsibility is to compile technical files according to the new requirements, to ensure their timely submissions, and to conduct efficient communication with the Notified Body during the assessments. After the successful transfer period the work continues with new product submissions, and the continuous post market surveillance activities of the Inion products.
Suitable background is minimum 5 years of work experience in the regulatory affairs of medical devices and academic degree of education. Clinical background and earlier productivity in medical / technical / scientific writing are an advantage. Fluent written and spoken English, and ability to create professional and consistent documentation in an organized and timely manner is a key requirement to succeed in this task. Communicating with internal teams and external parties to pull all required parts together is part of this task.
You will be supported in this task by the dedicated and committed Inion team with long term in-house experience of the products and requirements, as well as submission planning, gap analysis, ready procedures and technical file framework. The workplace is located at our Tampere office.