Overview:
Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Brukers high performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity, and customer success in life science molecular and cell biology research, in applied and pharma applications, in microscopy and nanoanalysis, as well as in industrial applications. Today, worldwide more than 8500 employees are working on this permanent challenge at over 90 locations.
Are you enthusiastic about electrical safety and product certification and can draw on a wealth of experience in the field of in vitro diagnostic medical device certification or have you gained initial experience as an engineer in this field and are interested in further career development?
Then the following tasks await you in our team:
We are looking as of now for a
Engineer Regulatory Affairs
(m/f/d)
Responsibilities:
You will be jointly responsible for the international certification and approval of our IVD products in the areas of electrical safety and EMC, as well as material compliance.
You will coordinate the process of applying for and obtaining certifications in cooperation with approval authorities and test centers.
You will also support internal test procedures together with our testing department.
You will research and clarify approval requirements, monitor them regularly and prepare approval documentation.
You will support and advise the development department with regard to legal and normative requirements in order to take these into account during the complete product lifecycle.
Qualifications:
Degree in electrical engineering, medical technology or similar, or further qualification as a state-certified electrical engineer
Ideally, in-depth experience of supporting approval procedures in the fields of electrical safety and EMC
Knowledge of appropriate standards (e.g. IEC 61010-1:2010, IEC 61010-2, DIN EN 61326-1, DIN EN 61326-2-6) and knowledge of the EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, material compliance (e.g. RoHS) and preferably also the EU Machinery Directive 2006/42/EC respectively Regulation (EU) 2023/1230 on machinery.
Ideally knowledge of the CE directives and the IVD Regulation (EU) 2017/746
You have strong communication skills (German and English) and technical expertise when working with internal and external interfaces.
You work in an analytical, structured, precise and conscientious manner.
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