To be successful in the above-mentioned roles you will have:
Quality Management Systems Auditor
Required Qualifications:
-University/College degree in fields of Medicine, Pharmacy, Engineering, Biology, Chemistry/Biochemistry, Materials Science, Physics/Biophysics, Biomedical Technology
-4 years of work experience related to:
* Medical devices industry or similar sectors (e.g. pharmaceuticals industry), with scopes such as: research and development, manufacturing, regulatory framework.
* Healthcare services, Universities, Organizations and bodies performing: Audits, Clinical evaluations, experimental and/or clinical research.
* Application of medical technology and use in healthcare services and patients.
* Performance of laboratory tests and trials on medical devices to check their compliance with national or international standards
* Performance tests and , evaluation studies or clinical trials of medical devices
-Certified training on ISO 9001:2015 and/or ISO 13485:2016
-Excellent knowledge of oral and written English
-Computer use literate
Preferred Qualifications:
-Certified training on ISO 14001:2015, ISO 37001:2016, ISO 27001:2022
Medical Device Product Reviewer
Required Qualifications:
-University/College degree in fields of Medicine, Pharmacy, Engineering, Biology, Chemistry/Biochemistry, Materials Science, Physics/Biophysics, Biomedical Technology
- Familiarization with EU devices legislation on medical devices, and relevant guidance documents including the general safety and performance requirements (set out in Annex I of the Regulation 2017/745)
- Proper knowledge of the related harmonized standards, common specifications (CS), risk management and guidelines documents, as well as experience in the respective sector related to the medical device technical documentation
- Proper knowledge and experience regarding the conformity assessment procedures as compliance evaluation processes determined in Annexes IX to XI of regulation 2017/745
- Ability to draw-up records and reports justifying the appropriate completion of the relevant conformity assessment activities
-Work Experience:
* At least 4 years of professional experience in in the field of healthcare products or related activities such as in manufacturing, auditing or research. Two out of these four years shall be in the design, manufacture, testing or use of the device or technology to be assessed , or related to the scientific aspects to be assessed. Experience related to the specific aspects to be assessed also includes Technical Documentation reviews under MDD or MDR in a specific type of device or technology.
-Certified training on ISO 9001:2015 and/or ISO 13485:2016
-Excellent knowledge of oral and written English
-Computer use literate
Preferred Qualifications:
-Certified training on ISO 14971:2019, ISO 11135:2014, ISO 11137:2013, ISO 10993 series
In case you are interested, send your CV at: Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε.
