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job category
manufacturing & production
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)
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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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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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qualifications
- Bachelor’s degree in Engineering; preferably Industrial / Mechanical/Material Engineering
- Biomedical Engineering.<br>Excellent command of both written spoken English; German is an asset.<br>Experience in product risk management in medical technology is an asset.<br>Experience with the relevant standards (DIN EN ISO 14971
- 13485; IEC 60601-1) in the field of medical technology is desirable.<br>Knowledge/experience of/with ISO 13485.<br>Experience in using a risk analysis tool is desirable.<br>Good knowledge of MS Office applications.<br>Able to work with multinational teams.
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