Do you have diverse experience on quality management and regulatory compliance within the IVD / Medical Device industry? Are you passionate about working in the industry and developing your expertise even further? Would you like to share your experience in helping various companies to meet the evolving regulatory and quality management system requirements? If you answered yes, you might be the senior 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.

What we expect from you:

  • Strong work experience in regulated IVD/MD industry
  • Demonstrated knowledge of MDR/IVDR and applicable horizontal standards and experience in interpreting these requirements in  various practical situations. Experience on the requirements of other key market areas, such as the USA or China, is a benefit
  • Experience in compiling technical documentation and various reports, protocols, SOPs and other documents alike in accordance with applicable requirements. Specific experience on clinical/performance evaluation is considered a benefit
  • An applicable scientific or technical degree
  • Service- and solution-oriented mindset
  • Ability to work both independently  and in a team with other Medfiles’ or our clients experts
  • Fluent verbal and written English skills. Basic communication in Finnish is a benefit, but not a must 
  • Possibility to travel, also abroad

In your work, you will be able to utilize and develop your expertise in our versatile client projects. We offer a wide, interesting and versatile expert position in our international, flexible and inspiring work community. In addition to flexible working practices like remote work possibility, we support the well-being of our employees with a variety of benefits.

For more information on our company and the position, please contact Regulatory Affairs Manager Päivi Turta on 5.10.2021 and 26.10.2020 at 15-16.30 by phone, +358 50 3130 323, or by email paivi.turta@medfiles.eu at your convenience.

Medfiles offers comprehensive expert services for companies working with medical devices and IVDs covering the entire product life cycle. Additional information and examples of services can be found in https://www.medfiles.eu/services/regulatory/medical-devices-and-ivds/.

Please send your application and salary request in English by 12.11.2021. 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.

Osaamisalue:

MedFiles Oy

Medfiles, a leading Nordic & Baltic CRO, supports its clients on the path to commercialisation with an array of services related to human and veterinary medicines, food and food ingredients, medical devices and cosmetics.
We as well offer a complete range of product development process, starting with pharmaceutical development with quality control laboratory analyses (chemical and microbiological), implementing clinical trials (phases I to IV) and dealing with regulatory affairs (e.g. marketing authorisation, pharmacovigilance) culminating in our “one-stop-shop” service package.