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Associate Counsel And Compliance Officer
Refer job# EEVA152995
Associate Counsel and Compliance Officer The candidate will be responsible for auditing processes against company Quality System policies, and for supporting Quality System objectives across company. Contract review and management, as required. Tracking contracts for signature to completion. Manage document control system, including authorized templates and litigation hold records. Assist in preparation of regulatory submissions to the FDA and other governmental agencies. Oversight of company insurance coverages and customer requirements. Monitor laws, regulations and best practices that control businesses and employment activities and maintain related company policies and procedures. Provide legal analysis and advice on business, employment, and regulatory matters. Ensure that company's Quality System processes are conducted properly by conducting internal audits according to the compliance calendar. Document process validation, findings, and non-conformities in audit reports. Manage corrective and preventive actions (CAPA), perform investigations, root cause investigations, corrective action plan and implementation, and effectiveness verification plan and implementation. Collect and report Quality metrics and data as required. Investigation, evaluation and reporting of adverse events incidents or device malfunctions as required by FDA and international regulatory authorities. Evaluate quality events, incidents, queries, and complaints. Oversight of legal sufficiency of internal learning management system courses.

The candidate should have Juris Doctor from ABA accredited law school. Must be licensed to practice law in good standing with the Texas Bar. 3+ years as a licensed attorney is required. should preferable have Experience as a Quality or Compliance Officer, as an Auditor, or Inspector. Experience working within a Quality System for production of medical devices, especially software as a medical device is desired. An auditor certificate (Certified Quality Auditor) from a recognized organization (such as American Society for Quality) is desired. should preferable have Experience with the preparation of FDA 510(k) and denovo applications. should preferable have Some computer programming experience. The job does not include computer programming but many of the processes in the quality system relate to computer programming. Experience with Github is desired.
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