We have an immediate opening for a full-time regulatory compliance specialist at our facility in south austin, texas. ***please submit your reply along with your cv/resume attached as a word doc/pdf file over here. ***job summary: we are a private laboratory providing stem cell processing and storage services. This position is responsible for reading and interpreting all applicable international, federal, state and local regulations for our industry and advising senior management on recommended actions to insure compliance with those regulations. The primary regulations applied to us are cfr title 21 section 2171.10 however there are others which are also relevant. ***specific knowledge of these are not required however it would provide a large advantage over other applicants. ***general knowledge and experience with fda, cglp, cgtp, osha, iso, and other regulatory structure is required. In addition to usa fda regulatory compliance this position would help to insure our compliance with the uk human tissue authority (hta) regulations as they apply to our industry. ***a successful candidate will have the following attributes: some biological lab experience including mammalian cell culture is preferred quality assurance experience is required. regulatory compliance experience require however extensive experience working in a regulated lab may substitute depending on the circumstances. have a bs degree with 5 year of relevant experience or an advanced degree with 2 year of relevant experience. some previous personnel management experience is desired but not required. be familiar with reading and writing sop’s, capa’s and risk analysis. be familiar with conducting internal regulatory audits. ***please attach your cv/resume here to apply. ***note this full-time, on-site job position does not provide visa sponsorship.
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