15900 Valley View Court Syllmar, CA 91342
Voca Professional has immediate openings available for Coordinator professionals in Sylmar, CA!
Voca connects professionals with fantastic companies nationwide. Our goal is full partnership with our employees, providing the tools, guidance, and opportunities to help reach their individual goals. Voca provides benefits including insurance, 401k, and dedicated support!
Assignment details are provided below, we’re very excited to hear from you!
Working under direct supervision, the Patient Records personnel must perform accurate data entry to register and update device implant records for the lifetime of each patient and/or device. The coordinator must implement outstanding data analysis while maintaining complex spreadsheets and matrixes. Provide after sale customer service support to patients, physicians, hospitals and sales representatives using bradycardia and tachycardia devices. Insure compliance with DWI's and the FDA Device Tracking Regulation of the Safe Medical Device Act of 1990. Does not require instructions for routine assignments; requires some general instructions for new or special assignments. Ensures that quality of services meet internal and external customer requirements.
1. Process incoming device registration forms, hospital device tracking reports and miscellaneous mail adding "New"or modify "Existing" patient, practitioner, hospital and/or procedure data.
2. Responsible to Proof registration forms after data entry and process patient ID cards.
3. Provide all callers with professional and courteous customer service by giving them accurate and timely information.
4. Ability to communicate independently with other divisions of the organization. Provide registration data and custom reports as required by sales management, inventory control, the field sales force, regulatory affairs and Quality departments. Obtain complete and accurate data, along with contact and return information, to facilitate prompt report generation and turnaround time.
5. Apply good judgment and critical thinking skills to research databases and work with the field sales force to verify incorrect labeling issues, verify and question registration information, document humanitarian registration data and expired or demo product statuses for all bradycardia and tachycardia devices to insure device tracking compliance. Review and update PDT data received from competitive manufacturers.
6. As assigned, process exception reports from SSDI searches to determine the death status and/or current address of selected patient populations having bradycardia or tachycardia devices. Update appropriate database records.
7. Contact a random sampling of patients semi-annually, by phone, as part of the periodic device tracking system audits as required by the FDA tracking regulations. Maintain and process complex Excel spreadsheets and audit questionnaires used in the preparation of a final report to Regulatory Compliance.
8. As assigned, using internet skills, verify weekly Trillium address exception report and update patient addresses as appropriate
9. Maintains regular, reliable, and predictable attendance. Complies with U.S. Food and Drug Administration regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors and vendors.
10. Performs other essential functions and responsibilities as determined by the Company from time to time.
11. Work additional hours, days or schedules (including other shifts, weekends, and/or holidays), if needed.
Specialized training/equivalent related experience. Minimum of five or more years of demonstrated experience in medical records and regulatory affairs/marketing. Minimum of two to three years experience in the following areas: customer service environment where telephone skills were used; data entry and record keeping functions of a medical device manufacturer, distributor or user facility; MS Office Software products (Word, Excel, Access, etc.) Demonstrate keyboard and organizational skills, attentive to detail, ability to work under general supervision and handle multiple assignments simultaneously. Demonstrated communication skills, both oral and written. Ability to use personal computer applications to manipulate databases. Demonstrate the ability to understand and comply with applicable US Food and Drug Administration (FDA) Regulations and Company operating procedures, processes, policies and rules. Must be able to use discretion and handle sensitive/confidential information. Must be able to maintain regular and predictable attendance.
Specialized training in and working knowledge of data entry and record keeping functions in a medical device manufacturing environment or equivalent. An applicable Associate Degree or relevant completed college work is preferred. Working knowledge of FDA Patient Device Tracking Regulations and previous experience using an ERP software package. SAP knowledge is preferred. Familiarity with WIN_ZIP, WS_FTP or similar file transfer protocols.
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