Aufgaben
* As Director Quality and Regulatory Affairs (m/w/d) you support business units and functions in creation, implementation and maintenance of processes and related documented information.
* You are accountable for the effectiveness of the quality management system and corresponding certifications for the EMEA sales organisations.
* You will be responsible for regulatory compliance
* You will be responsible for product registration in EMEA countries
* You are in charge of the implementation of Field Safety Corrective Actions in the EMEA region
* You ensure post market surveillance obligations are fulfilled according to the relevant regulations
* You will be leading a team of 4
* You need to be based in the Hamburg office
Qualifikation
* You have a university degree or similar qualification
* You describe yourself as an experienced QMRA Lead
* You have a proven knowledge of ISO 9001:2015 / ISO 13485:2016 and IVDR
* Ideally you have a background knowledge of Laser and X-Ray regulations
* You bring a business driven attitude
* Your communication skills are excellent and you are able to effectively communicate across all levels of the EMEA organization and work productively with others in a team environment
* You are fluent in English and German language. Further languages skills are a plus
* Risk management knowledge is a plus
* You need to be based in Hamburg and will travel to other business locations on a constant basis (<25%)
Benefits
* Flexible working hours, incl. mobile work
* 30 days of holiday time each year
* 13.5 salaries a year
* Regular training courses
* Extensive company pension scheme
* Payments towards an employee savings plan
* Preventive healthcare, free beverages & fresh fruit and vegetables daily
* Joint company events and activities
* Interesting, diversified field of activity in an international working environment
Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.