Director Quality and Regulatory Affairs mfd

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 XRay 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
• 135 salaries a year
• Modern office and inspiring working environment
• Subsidized meals in the neighborhood of our office (Stadtkche)
• 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 wellbeing
• 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.