Anthony Hussey Email and Phone Number

• Product registration filing support for US, Canada, Asian Pacific and Latin American countries for IVDs/ Medical Devices for new submission, license amendment and change notifications• Worked with pharmaceutical partners to develop global regulatory plan for companion diagnostic devices• Helped client with regulatory assessment and change implementation during acquisition• Developed new regulatory policies, processes and SOPs and provide internal training • Helped clients with distributor screening and due diligence for potential in-country representative• Negotiated and interacted with regulatory authorities during the development and review process to ensure submission approval• Reviewed and approved advertising and promotional items to ensure regulatory compliance• Worked with marketing and product development team to support new product development and change notifications process• Interpreted and applied FDA regulations to business practices and provides regulatory input, advice, and guidance to the client• Evaluated regulatory management database and helped with implementation

• Worked with R & D, marketing and other groups to compile appropriate technical documents for regulatory submissions in support of the development project• Responsible for worldwide product registration especially for US, Canada and Asian Pacific area• Successfully got more than 600 product licenses approved for new product registration, license renew and license modification for Class II and III devices in more than 18 countries• Develop and maintain the Technical File, Organize and maintain MSDS, technical dossiers• Worked with international regulatory affairs to support distribution markets to coordinator product registrations

• Performed process assessment and gap analysis, identifying and quantifying areas in the business were processes and/or operating profit can be improved or compliance issues exist• Elicited and documented requirements for Health Care Reform High Risk Pools• Documented internal Billing and Claims adjudication processes for NASCO• Act as liaison between the business units, technology teams and help desk to help resolve issues in a timely and accurate manner