Job Summary: Cord Blood America, Inc. (CBAI) is seeking a hands-on Quality and Regulatory Affairs Manager. This position supports the sales and operational activities related to enrollment and customer service for customers who purchase cord blood preservation services. The Quality and Regulatory Affairs Manager ensures the quality program as defined in the company¡¦s documented processes satisfies the requirements of regulators, including the FDA, and the states of NY, NJ and CA. In return, CBAI offers ground floor growth in one of the emerging sectors of the new economy. The position will be based in Las Vegas at the company¡¦s newly announced laboratory for cord blood processing and storage. Specific Responsibilities Include: „« Check information and complete set up of customer file folder, including filing of subsequent paperwork. „« Contact customer to obtain missing paperwork, to notify of need for maternal blood redraws, to provide notification of cord blood receipt and to verify receipt and mailing of Certificate of Results (lab report). „« Maintain all relevant customer data into database (NetSuite), including tasks for financial accounting. „« Fax collection instructions to customer¡¦s obstetrician and hospital labor and delivery department where necessary. „« Secure and review monthly reports from vendors. „« Compile trends in vendor performance for presentation to Management and Medical Advisory Board „« Maintain company¡¦s approved vendor list „« Schedule and arrange vendor audits „« Oversee implementation of corrective actions relating to vendor audits, monthly deviation, adverse reactions and error reports. „« Monitor quality program which includes proper document management protocol for all company SOP¡¦s. Notify company management of deviations from the Quality Program. Minimum Requirements „« Bachelors Degree „« Systems thinker, capable of process management „« Quality management experience. „« Effective written and verbal communication skills including document management. „« Experience demonstrating strong organizational skills. „« Effective problem solving skills and multi-tasking skills. „« Required experience with PC, basic Windows navigation skills, Word and Microsoft Outlook knowledge. Preferred: „« Experience in laboratory environment „« Experience working with regulatory agencies, FDA. Benefits: „« Medical and dental coverage „« 401K „« Paid vacations and holidays „« Casual dress environment „« Salary commensurate with experience Location: Las Vegas Compensation: $50,000 - $65,000 per year total compensation (salary + bonus) based on experience OK to highlight this job opening for persons with disabilities Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests. nevada