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ARM Life Sciences have partnered with a Medical Device company in the Mainz region in Germany, with leading manufacturing facilities in the EU and USA.
Their young R&D team is built by professionals from molecular biology, protein chemistry, and cell culture, with extensive experience in scientific questions and project management and their main focus is to develop new, innovative products based on their clients needs and market requirements.
Currently they are looking for a Regulatory Affairs Manager to strengthen their team.
Working within a dedicated regulatory affairs team, the successful candidate will support the programme of work required to deliver the regulatory strategy and provide an efficient regulatory and registration service worldwide.
Regulatory experience gained within medical device and IVD environment is required.
Supporting internal and external Audits is pivotal to the success of the role and this will require you to provide information on product registration as well as general regulatory support and insights.
Other responsibilities for this role include:
- Creation and maintenance of technical documentation of the medical devices (incl. IVD reagents and instruments, ELISA, IFT)
- Direct contact with authorities such as the FDA and NMPA
- Implementation of the new IVD Regulations
To be consider you must have the following:
- Life Science studies (ideally with a doctorate)
- 2-3 year experience in Regulatory Affairs
- Experience in approvals of In-Vitro diagnostic products
- Strong customer focus
- Fluent German and good written and verbal communication skills in English
This is a permanent, full time position offering a base salary (flexible and dependent on level of experience).
If interested in applying , please send a copy of your CV over to firstname.lastname@example.org or call 0049 711 2295 4542 and I will be in touch.
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