We are hiring a Quality & Regulatory Affairs Specialist
We are looking for an experienced Quality & Regulatory Affairs Specialist to join our Quality management team. We offer you an opportunity to utilize your existing experience and develop your skills in the quality and regulatory field of medical devices.
In this role, the development and maintenance of our quality management system is one of your key tasks. You will be implementing the applicable regulatory requirements to our processes and ensuring the effective operation of these activities. As a part of your responsibilities, you will be coordinating our post-market surveillance and vigilance activities.
As a Quality & Regulatory Specialist, you will support our software development team to achieve compliance with applicable regulations and standards. You will also be involved with the preparation of technical documentation and product certifications and registrations for different market areas.
Although you will be working as a member of quality management team and in close collaboration with our software development team, you are a person who can work independently and take initiative to continuously improve our processes and quality management system.
Required knowledge and experience: - Experience on developing and maintaining quality management system - Experience on working with product certifications and registrations - Knowledge on applicable regulations and standards (particularly ISO 13485, ISO 14971, IEC 62304, EU MDR and US FDA QSR) - Fluency in English (both spoken and written)
Seen as a benefit: - Good documentation practices - Understanding medical device software development - BSc degree or higher on any relevant area of expertise
What we offer: - An essential position in a growing high-tech company with highly motivated team - An opportunity to develop your professional skills in a versatile manner - A chance to affect your working environment and career path - A competitive salary in the range of 3500–4500 €, depending on your previous experience, and benefits such as a lunch benefit, sports, culture and massage vouchers and leisure-time insurance. - An opportunity for hybrid/remote working, our offices are located in Oulu and Helsinki
Please, note that the position will be filled as soon as the suitable person is found.
For more information, please contact Dr . Timo Koskela, CFO,
Cerenion Oy is a medical device company providing advanced brain monitoring solutions for improving patient care. Currently, we have 16 employees and offices in Oulu and Helsinki. Our C-Trend® technology provides a new level of ease and confidence in brain monitoring. Based on Artificial Intelligence (AI), the C-Trend® medical software processes the complex EEG recording to produce a set of easy parameters to aid medical professionals in clinical decision making. https://www.cerenion.com
Cerenion Oy has received support from the European Regional Development Fund of the European Union.
Cerenion Oy Elektroniikkatie 3 90590 Oulu FINLAND
Cerenion Oy Firdonkatu 2 T 63 00520 Helsinki FINLAND