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Will you be part of fulfilling Radiometer’s value proposition Whatever comes next, we make sure life comes first? Here is your chance to join our Regulatory Affairs team in Radiometer, a fast growing company in Bio valley of Turku.
We are looking for highly skilled
SENIOR REGULATORY AFFAIRS SPECIALIST.
The vacant position is based in Turku and part of the RA team supporting Radiometer's immunoassay and sampler portfolio. The team consists of 5 employees in Denmark and 3 in Finland. Our background overall in RA lies within pharmacy, biology, chemistry, engineering and biomedical/medical engineering.
Your tasks will vary from supporting the efficient production of test kits, by regulatory assessment and implementation of changes. Then you will work together with colleagues to answer a tricky question from our notified body. Together with the global project team, you will find the best way to regulatory approval of a new product.
Coming in with experience from a similar job, you have worked with R&D projects, STED files, 510k submissions and other major markets globally. We want you to share your knowledge with the team and take lead. You will support our strategic projects and find a way to regulatory approval in cases with many unknowns, and in this process lead authority interactions. As a specialist in this team, we also encourage you to take part in maintaining and improving regulatory processes in the department.
To be successful in this role it's a must to have strong communication skills and build up good cross-functional collaborations with other departments, both in Turku and Denmark.
We expect from you
- The preferred candidate holds a Master Degree in Science, Engineering, Pharmacy, Biology or in Biochemistry.
- At least 8 years of experience with the IVD legislation (or MD) on different markets worldwide.
- You have proven record of compiling regulatory files and achieving approvals worldwide (e.g. 510k) including maintenance of documentation
- Experience with strategic RA support to cross-functional projects.
- Experience with work relations in different cultures.
- Strong technical knowledge of immunoassays and terminology
- Strong analytical and organizational skills with the ability to prioritize competing demands
- Independent and Goal-oriented working style
- You have the capability to identify issues and take appropriate actions according to company guidelines and policies
We offer you
- An outstanding opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. In Finland, Denmark and abroad we have hardworking colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', flexibility, opportunities for training and career development, and a wide range of staff benefits.
- We are using LEAN tools in our company and you shall have numerous opportunities for personal development in LEAN tools and practices.
We encourage you to apply by May 23rd, 2021 at the latest. Please attach your CV and other relevant documents.
We continuously assess candidates and invite for interviews, so please don’t hesitate to send in your application. Any questions regarding the position can be directed to Director, RA immunoassay, Trine Thing Østerby at: +45 41889524
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