Develop and refine robust Supplier Quality program. Hire and train team, audit key vendors

Develop FDA-compliant quality system, hire and develop internal QA team.

Responsible for working with all stakeholders to define and implement the company’s regulatory strategy in support of CLIA, ISO, CE-Mark, FDA submission and QSR regulations and to oversee the Quality Management System. The Quality Management System assures compliance with regulations and standards set forth by regulatory and accrediting agencies. Establish effective partnerships with internal staff to facilitate the timely identification and resolution of compliance / quality matters as well as opportunities for quality process improvement. Track / trend data and provide reports to management for evaluation. Oversees design control for products regulated by the FDA. In addition, oversees the company’s document control function, regulatory submissions, and internal and external audits.

Responsible for contributing to the development and implementation of regulatory and quality and regulatory-related tasks associated with the XDx Quality system to assure compliance with regulations and standards set forth by regulatory and accrediting agencies. Build and maintain the Internal Quality Audit system. Conduct supplier assessment audits/surveys; contribute to the definition of requirements for XDx approved supplier lists for materials, equipment and services.Manage CAPA system; coordinate MDR investigations; interact with all key internal customersBuild and manage the Document Control system to assure compliance to in-house and/or external specifications and standards such as GMPs and ISO regulations in the role of System Administrator; close integration with IT and all internal users.

Guide clinical operations which facilitate the design, implementation and execution of clinical studies leading to the development of novel molecular diagnostic tests.Conducting and monitoring of clinical trials in accordance to FDA, GCP, and ICH guidelinesEnsure data integrity of monitored clinical dataManagement, training and mentoring of CRAI, II and III, working closely with Director, Clinical OperationsRevised existing SOP's and established new SOP’s as needed.Design control project management in conjunction with Regulatory DirectorSupport Regulatory Department with regulatory filings.

Surgical medical device company utilizing balloon catheter devices for ENT application with development and implementation of proprietary devices used for ENT applications.Clinical trial manager for R&D projects

•Developing, conducting and monitoring clinical trials in accordance to FDA, GCP, and ICH guidelines for Class II in-vitro diagnostic medical devices.•Developing and conducting post-market user studies. •Writing peer reviewed papers for journal publications, poster presentations and white papers.•Supporting Regulatory Department with regulatory filings. •Establishment of new SOP’s as needed. •Principle Investigator for in-house, IRB-approved Clinical Studies and blood collection Protocol for Metrika. •Management of NGSP-Certified Level II Laboratory for Metrika•Management and mentoring of laboratory technologist and technical support staff.•Ensuring annual re-certification of Level II NGSP status for laboratory and A1cNow+ product. •Providing clinical expertise to Marketing, Research, Development and Engineering Departments for new product development.•Performing internal audits of company Quality System.•Providing product training to sales, marketing, technical support and customers.•Educating new sales, marketing and technical support staff on use of A1C in diabetes care.•Member of the NGSP Steering Committee (www.NGSP.org), as one of two manufacturer’s representatives for 3 year term expiring in 2007. NGSP’s mission is standardization of A1C assays worldwide.

•Developing, conducting and monitoring clinical trials in accordance to FDA, GCP, and ICH guidelines for Class II in-vitro diagnostic medical devices.•Developing and conducting post-market user studies. •Writing peer reviewed papers for journal publications, poster presentations and white papers.•Supporting Regulatory Department with regulatory filings. •Establishment of new SOP’s as needed. •Principle Investigator for in-house, IRB-approved Clinical Studies and blood collection Protocol for Metrika. •Management of NGSP-Certified Level II Laboratory for Metrika•Management and mentoring of laboratory technologist and technical support staff.•Ensuring annual re-certification of Level II NGSP status for laboratory and A1cNow+ product. •Providing clinical expertise to Marketing, Research, Development and Engineering Departments for new product development.•Performing internal audits of company Quality System.•Providing product training to sales, marketing, technical support and customers.•Educating new sales, marketing and technical support staff on use of A1C in diabetes care.•Member of the NGSP Steering Committee (www.NGSP.org), as one of two manufacturer’s representatives for 3 year term expiring in 2007. NGSP’s mission is standardization of A1C assays worldwide.