Bilingual QA & Regulatory Admin Assistant

Under the direction of the QA/QC Manager, responsible for administrative support and ensuring that SLI obtains all necessary regulatory approvals and continues to maintain these approvals. Requirements Associate’s degree or equivalent Bilingual in English and Spanish Good organizational skills and manual dexterity Understanding of medical terminology Accurate data entry skills Good verbal and written communication skills Working knowledge of Outlook, Word, Excel and Visio Valid driver’s license, current proof of insurance, and clean driving record Responsibilities Create and maintain facility registrations and any other licenses or required regulatory documents. Maintain a log of all regulatory licenses with appropriate renewal dates. Research regulations and standards for new and existing products to develop regulatory strategies. Compile regulatory submissions such as 510(k) filings, PMA, etc. Review CE Marking Technical Files to determine gaps and any necessary ongoing activities to maintain compliance with current regulations and standards. Review Design History Files to determine gaps and any necessary ongoing activities to maintain compliance with current regulations and standards. Identify and revise outdated established procedures and assist with revisions of established procedures. Correspond with regulatory agencies and individuals by phone, email or fax as appropriate to follow up on issues as requested. Prepare monthly books for QMR. Create project plans and act as project manager to implement plans in QA and RA. Host facility regulatory inspections and follow-up action results. Internet research as requested for regulatory issues. Plan fire drills and conduct practical simulations. Act as HIPAA Privacy Officer. Follow up on action items to comply with the Safety Management System. Ensure compliance with blood product lookback requirements. Maintain a clean and organized work environment. Regular, reliable and predictable attendance. May perform other job related duties as assigned. May be assigned to any Scantibodies location for any period of time. We offer a comprehensive benefits package to include paid sick, vacation, medical, dental, vision, life insurance and 401(k). #J-18808-Ljbffr Scantibodies Laboratory