Risk Management Engineer İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
Qualifications:
- Bachelor’s degree in Engineering; preferably Industrial / Mechanical/Material Engineering, Biomedical Engineering
- Excellent command of both written & spoken English; German is an asset
- Experience in product risk management in medical technology is an asset
- Experience with the relevant standards (DIN EN ISO 14971, 13485; IEC 60601-1) in the field of medical technology is desirable
- Knowledge/experience of/with ISO 13485
- Experience in using a risk analysis tool is desirable
- Good knowledge of MS Office applications
- Able to work with multinational teams
Job Description:
- Ensuring the risk management process in accordance with applicable standards and regulations
- Creates, reviews and maintains risk management file (RMF) according to established procedures and relevant regulations (MDR / 21CFR820)
- Implementation of ISO 14971 in the internal risk management process for the medical device during the entire life cycle of the product
- Actively participates in R&D study activities, contributing to the identification and assessment of the key risks
- Preparation of benefit / risk assessments in collaboration with the medical experts
- Maintenance of the risk management tool used
- Support of the clinical evaluation studies
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