Director Quality and Regulatory Affairs (m/w/d)

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.

Responsibility

• 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 

Qualification

• 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%)

Your 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.