Director (F/m/d) Quality and Regulatory Affairs
vor 1 Tag
Aufgaben
- 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
Qualifikation
- 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, 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
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