Regulatory Affairs and Clinical Research Manager
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Location
Munich
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Sector:
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Job type:
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Salary:
Competitive
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Contact:
Leah James
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Contact email:
l.james@hamlynwilliams.com
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Salary high:
0
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Salary low:
0
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Published:
about 1 month ago
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Expiry date:
2021-04-10
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Startdate:
ASAP
Hamlyn Williams has partnered with a Medical Technology company based in Munich that is in a Major phase of growth and looking for a Regulatory Affairs and Clinical Research Manager.
The role will involve:
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Taking a leading role in regulatory affairs and quality management
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Be responsible for the creation and maintenance of technical documentation for medical devices (SaMD, Class IIa) ensuring continued regulatory compliance with (EU) 2017/745 (MDR)
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Contribute to the clinical evaluation of our software products
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Identify and evaluate risks in our software systems according to ISO 14971 to reduce productrelated risks to a minimum
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Setup and implement multi-centre clinical research and validation studies and projects
As a Regulatory Affairs and Clinical Project manager you will need:
- Experience in clinical research / project management7
- Technical understanding and a strong interest in IT, medical device software and artificial
intelligence - Excellent organizational, analytical, project management skills
- Experience within Regulatory Affairs within the Medical device space
- German speaking