Regulatory Affairs Specialist (m/f)

REFERENZNUMMER:

306531/11

IHRE AUFGABEN:

-Know and apply guidelines provided by the company code of conduct and by relevant national laws
-Make sure that the medical devices are compliant with the product development process and with the applicable regulatory requirements (e.g. MDD 93/42/EEC)
-Organisation and administration of technical documentation
-Update the technical documentation regarding current and new regulatory requirements and make sure that the documentation is in accordance with EU and country specific requirements
-Evaluation of medical devices regarding their risk potential (based on EN ISO 14971)
-Establish and support product related information (e.g. IFUs, Surgical Technique guides)
-Support international releases of medical devices
-Prepare and support audits, Support optimisation of company internal procedures

IHRE QUALIFIKATIONEN:

-Scientific, medical or engineering background
-Profound experience in Regulatory Affairs (MDD 93/42/EEC) of Medical Devices (focus on Class l, lla and llb)
-Experience in US Regulatory Affairs preferable
-Fluency in English and German preferable
-Pragmatic and solution-driven working style, ability to work under pressure, communicative team player

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager