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.
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Zuletzt aktualisiert am 19.04.2024