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Regulatory Affairs Manager

Be part of a growing global CRO specialized in medical devices, dedicated to accelerating the development and commercialization of innovative technologies. A career at genae means your ability to challenge yourself and have an impact.

Germany or Belgium

You take responsibility to ensure clinical trial submissions for medical device trials in Europe are performed according to the relevant EU and national regulations and applicable procedures and will act as an intermediary between the different parties involved.

Job objectives
You pro-actively identify regulatory related issues and set-up strategies to handle this efficiently. You’ll guide and support members of the project team (incl. local consultants) to ensure adherence with regulatory requirements, timelines and budget. Furthermore, you’ll follow-up on the appropriate development and collection of the required regulatory documentation and review and/or assist in the development of study documentation such as protocols, patient documentation and investigator brochures. Finally, you’ll coordinate and cooperate with third party vendors if applicable.

You preferably have a higher educational degree (BSc, MSc) in a medical or science-related field and at least 3 years of experience in clinical research, preferably in the start-up phase of medical device trials. In case of no clinical trial experience, candidates experienced in technical file compilation, Clinical Evaluation Report writing, Risk Management would also be considered.

You have hands-on experience in preparing, reviewing and submitting regulatory documentation to ethical committees and competent authorities in different European countries.

You have the ability to be the first point of contact with the client and work according and towards expected timelines and within budget. You take strong initiative and are able to work with minimal supervision. You’re fluent in English and have strong organizational, collaboration and team-building skills.

​​​​​​​Language requirements
​​​​​​​For Germany: German (Native or Business Fluent) and English
For Belgium: Dutch (Native or Business Fluent) and English
​​​​​​​Any additional languages are considered as a plus

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