Medical Device / IVD Expert

Would you be interested in working in diverse projects related to medical device / IVD regulatory affairs and compliance with evolving regulatory requirements? Are you passionate about working in the medical device industry and developing your expertise even further? If your answer is yes, you might just be the regulatory affairs expert we are looking for to join our team. Medfiles has offices in Finland and the Baltic countries, and you could be working in any of these countries.

As a regulatory affairs expert, you will be part of our Medical Devices Team offering comprehensive expert services to companies working with medical devices and IVDs, covering the entire product lifecycle. Additional information about our services can be found at https://www.medfiles.eu/services/regulatory-services/medical-devices-and-ivds/ 

You will mainly work on our client projects as an expert in your area of expertise and also support and coach other team members in assignments related to your area of expertise. Furthermore, this position and working in our diverse client projects gives you the possibility to widen your expertise beyond your present know-how and qualifications. In addition to client projects, all team members participate in internal development activities and client marketing.

• Relevant work experience in the regulated MD/IVD industry
• Demonstrated experience in one or more areas related to compliance with EU regulation (MDR/IVDR), for example in product compliance or manufacturer and QMS requirements. Experience implementing the requirements of the three key processes of clinical/performance evaluation, risk management and post-market surveillance/post-market clinical follow-up, is highly appreciated.
• At least a basic-level understanding of EU regulation (MDR/IVDR) and applicable horizontal standards (such as ISO 13485 and ISO 14971). Experience in interpreting these requirements in various practical situations or knowledge of requirements in other key market areas, such as the USA or China, is considered an advantage.
• Demonstrated ability to write scientific documents. Experience in compiling technical documentation, various reports, protocols, SOPs and other similar documents in accordance with applicable requirements is highly appreciated.
• A suitable scientific or technical degree
• Active approach and high motivation to widen expertise in both medical device regulatory affairs and quality management
• Service- and solution-oriented mindset, flexibility to work in diverse projects
• Ability to work both independently and in a team with Medfiles’ other experts or our clients’ experts
• Fluent verbal and written English skills. Basic communication in Finnish is an advantage, but not a must
• Willingness to travel occasionally, also abroad.

We offer an interesting and versatile expert position in our agile and inspiring, international work community. In addition to flexible working practices, such as the possibility to work from home, we support the well-being of our employees with a variety of employee benefits.

For more information about our company and the position, please contact Eric Schwandt, Head of Operations, Medical Devices, by phone, +358 447861228 or by email eric.schwandt(at)medfiles.eu.

Please send us your application and salary request in English by 24.3.2023. Don’t hesitate to apply already today – we review the applications as they come and will fill the position as soon as a suitable candidate is found.