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Regulatory Affairs Manager (m/f/d) in der Städteregion Aachen
Referenznummer: acjobs-st-53392

Adhesys Medical GmbH - Vollzeitbeschäftigung
Start ab sofort - Online seit dem 19.03.2020


Job-Zusammenfassung

Adhesys Medical GmbH is an international high-tech start-uppart of the Grünenthal Group. We developmarket innovative adhesives for medical applications. Our products can seal wounds on the skin as well as in the body within seconds.

At our location in Aachen we are hiring a

Regulatory Affairs Manager (m/f/d)
Creationmaintenance of technical documentation for medical device approvals in the Europeaninternational markets
Research of international regulatory requirementsguidelines for relevant changes
Execution of Europeaninternational medical device approvalregistration procedures
Processing of approvalregistration amendments
Advise colleagues on regulatory implications for product development, testing,manufacturing projects 
Communication with internalexternal parties
Active participation in cross-functionalinternational projects

Completed scientific, medical, engineering,technical studiesother relevant education
At least 3 years of professional experience in medical device regulatory affairs (experience with Class III medical devices desirable)
Very good knowledge of European medical device regulations, guidelines,standards (knowledge of US FDA medical device regulations desirable)
Experience in communication with Notified Bodies and/or the US FDA
Experience with quality management systems according to EN ISO 13485
Very good knowledge of EnglishGerman (writtenspoken)
Independent, structured,responsible work ethic
Very good writtenspoken communication skills

Young, dynamicinnovative environment in a high-tech company
Flexibilitystart-up mentality
Flat hierarchies
Fun at work in a motivated team

Bitte geben Sie bei Ihrer Bewerbung die Referenznummer acjobs-st-53392an.


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