Cindy Ni

• Perform gap analysis of QMS and Technical Documentation for EU MDR compliance • Update QMS • Prepare Technical Documentation, including clinical evaluation and PMS documents • Prepare risk management file • Prepare usability engineering file and testing • Handle all communications with Notified Body

Product: Class III implant • Develop strategies for registrations in China • Support all registrations in China, including testing, documentation review, deficiency letter, communication with lab and NMPA and over 15 licenses granted for now • Handle all technical communications with local and global team • Evaluate the impact of new or updated regulations and standards • Labelling and material review • Support Hong Kong registrations

• More than 20 years’ experience, over 10 yrs directly in China & Asia market and 10 yrs in Europe • Manage and support international registrations, focusing on EU, China, Asia, USA and Canada • Hands-on experience in regulatory strategy, risk management, usability, TD and communication with NB & CA • Material review • Build up and maintain QMS • Certified QMS auditor • Experience with on-site or remote audits from NB and CA, e.g. China, USA, MDSAP, Korea, Brazil etc. • Cover products of all risk classes

Products: endoscopes, HF surgical devices, navigation system, instruments • Handled over 15 new and change registrations in China, from setting up strategy, type testing, dossier preparation and review, handling deficiency letter, consultation meetings etc. • Provided strategic RA plan to support local manufacturing • Labelling and IFU review • Supported preparation for NMPA oversea inspection • Evaluated the impact of new or updated regulations and standards • Performed worldwide UDI evaluation

Products: surgical instrument • Built up new Quality Management System according to ISO 13485 and EU MDR • Provided trainings • Conducted audits

Products: Dermatological radiofrequency devices • Managed China projects to bring a non-medical device to medical device approval, incl. developing strategy, creating and review technical documentation, clinical trial CRO and protocol discussion etc. • Full assessment of regulatory access to KSA • Promotional material review

Products: IVD, i.e. SARS-COV-2 Test Kits, Control Set etc • Managed global registrations, including WHO EUL submission, Brazil, India, Thailand, Vietnam etc. • Assessed the regulatory entry approaches to different markets during pandemic time • Created and compiled Technical File • Created RA relevant SOPs, including IVDR, FDA etc. • Created and maintained RA database and evidences • Involved deeply in design change projects • Created and reviewed IFU and labelling

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