Under the direction of the Quality Assurance/Regulatory Affairs Manager, responsible for administrative support and ensuring that SLI obtains all necessary regulatory approvals and continues to maintain these approvals.
Create and maintain facility registrations and any other licenses or required regulatory documents.
Maintain a log of all regulatory licenses with appropriate renewal dates
Researches regulations and standards for new and existing products to develop regulatory strategies
Compiles regulatory submissions such as 510(k) filings, PMA, etc.
Reviews CE Marking Technical Files to determine gaps and any necessary ongoing activities to maintain compliance to current regulations and standards
Reviews Design History Files to determine gaps and any necessary ongoing activities to maintain compliance to 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Identify and revise outdated established procedures and assist with revisions of established procedures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
Take minutes for facility inspections
Internet research as requested for regulatory issues
Ensure compliance with blood product lookback requirements
Maintain a clean and organized work environment
May perform other duties as assigned
General Office Equipment
Associates degree or equivalent
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
Scantibodies Laboratories, Inc., is a 40 year old Biotech company located in the East County of San Diego. The activity of the organization is to develop, manufacture and continually improve products for the diagnosis of disease.
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