As the Director Quality and Regulatory Affairs (m/f/d) you support business units and functions in creation, implementation and maintenance of processes and related documented information.
Tasks
As the 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
Requirements
* 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
* 30 days of holiday per year
* 13,5 salaries a year
* Modern office and inspiring working environment
* Subsidized meals in the neighborhood of our office (Stadtküche)
* Public transport ticket (100% subsidized) or free parking space
* Bike leasing
* Subsidy fitness first gym
* Employee Assistance Program to support your health, mental and emotional well-being
* Comprehensive company pension scheme
* Joint company events and activities
Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.
Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas. In addition, Evident offers videoscopes, products for non-destructive testing techniques and for X-ray fluorescence analysis.