The IVD Assessor must be technically proficient and up-to-date in their professional knowledge and have a demonstrated understanding of the Australian therapeutic goods regulatory environment. You will operate well independently and within a small team and be proactive in meeting tight deadlines. This will require excellent verbal and written communication skills and the ability to interact effectively with internal and external stakeholders.
The key duties of the candidate include: undertaking evaluations and providing advice on technical aspects of IVD medical devices in relation to the relevant essential principles of quality, safety and performance and contributing to issues management and researching, interpreting and applying legislation and regulatory guidelines when undertaking IVD medical device evaluations
The candidate must have: an advanced science degree relevant to the field of Medical Laboratory Science or Biomedical science. The preferred candidate will have: experience in a field relevant to the manufacture and/or performance evaluation of IVD medical devices; experience in a pathology laboratory or other testing laboratory in the fields of immunohaematology (blood banking) or red cell serology and testing for viral infectious diseases using serological and/or nucleic acid techniques; experience in the application of published standards and guidelines for IVD medical devices (e.g. CLSI, NPAAC standards).
In return you will be rewarded with a generous salary package and excellent training. This role is a 6 month contract with the potential for extension. Candidates from Canberra, Melbourne, Sydney and Brisbane will be considered. Please contact Sean on 02 9431 2540.
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