SCL is proud to offer the following career opportunities:
Last updated on Thursday, December 03, 2009
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| Title: Manager, Regulatory Affairs |
| Department: QA & RA |
| Location: Santee, CA |
| Schedule: Mon-Fri, 1st Shift |
Description: Ensure that Scantibodies obtains and maintains all regulatory approvals of products and facilities. This person is a key driver of change within Scantibodies and is heavily focused on Improvements to products and processes. Experience must include 510K filings for in-vitro diagnostic devices or medical devises, Submission of pre-IND, IND, NDA/BLA applications for drugs and biologics, developing a regulatory strategy for the regulated products which ensures compliance with regulations and marketability of products. Management of Department personnel.
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| Requirements: Bachelors Degree, minimum of 7 years experience in regulatory affairs in similar industry, knowledge of GMP/QSR and ISO international regulations and standards which apply to SLI. Computer literate in MS Word and Excel and possess excellent communication skills. |
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