Director Quality and Regulatory Affairs (f/m/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.

Responsibilities 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 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%)

Responsibilities

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

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%)

Your 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.