Cindy Ni

Provide international regulatory strategies for projects Review and approve related project documents Manage and support CE and global submissions/renewal/annual report Manage and monitor change assessment and notification on global basis Develop regulatory SOP Build up and maintain regulatory database Track, understand and assess new or updated regulations and standards Manage global regulatory affairs team Review marketing material and labelling Certified QMS auditor

Handle CE submissions Support global submissions and ensure product licenses maintenance & regulatory compliance activities Make sure company’s and country-specific requirements are met Work closely with R&D team to provide regulatory strategies Review R&D documents, labelling, SOPs Proactively participate industry and HA activities Provide regulatory intelligence activities to facilitate the expedient review and approval of submissions Support quality management system audits worldwide

Manage and monitor all regulatory registrations, including new, renewal and variation for China; Support registrations for Asia Pacific countries; Build up and maintaining relationships with China testing labs and health agencies; Ensure timely awareness and understanding of regulations and standards released by government; Proactively participate in building up and maintaining RA database Involved in EU submissions for CE mark.

Manage and monitor all regulatory registrations Manage post-market surveillance Build up SOPs related for Surgical China, incl. complaint handling, adverse event reporting, correction, copy review and etc. Build up and maintaining relationships with health agencies to increase the credibility and image of B&L Regulatory Affairs function Cooperate with SFDA to organize Optic Forum from 2008 to 2010. People management, including development plan for team members, succession plan, JD development and etc

Managed timely entry of adverse events into complain system and manage field action reporting to SFDA to ensure full compliance with local regulation; Reviewed of labels and marketing material for compliance to SFDA advertising regulations; Took an active role in building customer relationships, both internal and external; Registered trademarks for China market

Was charge of regulatory registration for over 30 imported medical products and kept good relationship with health agencies; Planned, budgeted and implemented marketing plan, including activities, souvenir, brochure, advertisement, website and etc

Supported Regulatory Dept. to get SFDA certificates; Planned, budgeted and implemented MarCom activities of advertising, trade show, promotional events, website and etc.; Coached colleagues to design and execute projects of Six Sigma

Teacher of International Trade subject