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Bilingual QA & Regulatory Admin AssistantScantibodies Laboratory • Santee, California, United States
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Bilingual QA & Regulatory Admin Assistant

Scantibodies Laboratory
  • US
    Santee, California, United States
  • US
    Santee, California, United States
Jetzt Bewerben

Über

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Identify and revise outdated established procedures and assist with revisions of established procedures.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).
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  • Santee, California, United States

Sprachkenntnisse

  • English
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