Bilingual QA & Regulatory Admin Assistant

Scantibodies Laboratory; Santee (CA); On-site; Full time

Job description

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• Identify and revise outdated established procedures and assist with revisions of established procedures.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).