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Danaher Corporation Regulatory Profile for EU IVDR implementation in Finland

RA Professional

Will you be part of fulfilling Radiometer’s new value proposition Whatever comes next, we make sure life comes first? Then come and join our phenomenal international RA team.

In Radiometer’s RA/QA department we are Partnering for Impact to be a competitive advantage for reliable, fast, and easy patient diagnoses.

Your responsibilities

The vacant position is temporary and it is based in Turku and part of the RA team supporting Radiometers ImmunoAssay and sampler portfolio. The team consists of 4 employees in Denmark and 3 in Finland. Our background overall in RA lies within Pharmacy, Biology, Chemistry, and Engineering and biomedical/medical engineering.

In the area of Medical Devices and In Vitro diagnostics, the legislation is increasing worldwide. Lately a new regulation in EU has been adopted that will go into force in 2021 for Medical devices and 2022 for In-Vitro Diagnostics. In addition, an increasing activity is seen in the R&D area, which creates a need for RA to support projects and documentation. Also new legislation requires ongoing maintenance of summaries of documentation during the life cycle of products. The responsibility for creating and maintaining these summaries lies in RA and we therefore need you to participate in this important task.

To be successful in this role you will build on cross-functional corporation with QA, R&D, Operation, Sales and Marketing and other departments. Together with our local sales companies and Danaher's QA/RA organization, you will be responsible for preparing and compiling regulatory dossiers to ensure that their content is in accordance with internal and external guidelines and maintain current market approvals and documentation.

Requirements

  • The preferred candidate holds a Master Degree in Science, Engineering, Pharmacy, Biology, Biochemistry.

  • Preferably, experience with the medical device legislation (IVD, MDD) in EU or strong ability to learn.

  • Has preferably a proven track record of compiling regulatory files and achieving approvals, including maintenance of documentation

  • Preferably experience with work relations in different cultures.

  • Has preferably experience with RA support to cross-functional projects.

  • You have strong technical knowledge of immunoassays and terminology

  • You have strong analytical and organizational skills with the ability to multi-task and prioritize competing demands

  • Independent and Goal-oriented (reaching the goal that has been set within deadline).

  • In addition, it is expected you can take part in maintaining and improving regulatory processes in the department.

Our offer to 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. Both in 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.

Application

We encourage you to apply by December 3rd, 2020 at the latest. Please start the process by clicking "apply now". 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 important questions regarding the position can be directed to the hiring manager Trine Østerby at +45 41889524

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

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