Regulatory Affairs Associate
Since December 2014
D.O.R.C Dutch Ophthalmic research Center International B.V., Zuidland, the Netherlands, Ophthalmic surgical device company Duties: • Am project leader of medical device registration in China. Products include class I, class II and class III products. • Take multitasks, plan and manage 40’s registration projects. • Dedicate to take responsibilities, work spontaneously both independently and in a team. Interdisciplinary team working. Keep close contact with regulatory agencies, registration \ agent, testing centers, customs, customs declaration agent, distributors, and Research & Development department, to explain and deliver messages accurately to ensure the whole team understand well and work corporately. • Am aware of CFDA regulations, make strategic plans and take actions, to comply with all the applicable requirements & policies, and prepare documents for submissions. Draft dossiers and proceed for document notarization and/or legalization on request. • Support for registration testing, arrange samples and solve problems together with engineers for technical issues. Support for clinical research and collect clinical evaluation data, such as clinical user case report data and literature. • Do project cost-effectiveness analysis, schedule, control budget, and make feasible strategic decisions and solutions. Keep financial informative cost records. • Label design. • Take business travel on site.
Regulatory Affairs Associate
May 2013 --- November 2014
A medical device company specializing in Cardiology. Duties: • In charge of medical device registration in the CE and other assigned countries. Products including class I, class II and class III products. • Apply for free sale certificates online, draft dossiers and proceed for document notarization and/or legalization on request. • Maintaining regulatory documentation up to date for worldwide regulatory purposes. Manage regulatory data both physically and digitally. • Providing pre-marketing support to prepare regulatory submissions. • Work with international registrations, quality management senior consultant, Dekra, BSI Certification Auditors and GMP compliance to ensure high quality objectives and strategies. Am aware of ISO 13485, Medical Device Directive (93/42/EEC), international regulatory as well as standard requirements. • Take care of quality management system records in order to assure compliance with all applicable requirements. • Support for clinical research and development. • Record and document the post-marketing adverse event(s) and surveillance. • Work closely with Dutch CIBG Ministry of Health, Welfare and Sport Department, chamber of commerce, notary public office, embassy service agency and foreign embassies. • Send export and regulatory documents using international carriers, such as Fedex, UPS and DHL. • Prepare documents for regulator inspection. • Report to the CEO about the progress of registrations in different countries.
Office assistant (part-time)
July 2009 --- April 2013
Duties: • Provide administrative support to general manager. • Assist general office administration work. Organize office documents. • Sort incoming and outgoing mail documents and invoices. • Answer the telephones, provide receptionist services. • Organize meetings and events, and take meeting minutes.
Internship of Master of Science in Clinical Epidemiology
January 2011 --- August 2012
Project Title: Non-pharmacological interventions in cardiac syndrome X - a systematic review. Managed the project, monitored and reported the progress to ensure each objective is met on time, solved the problems during the procedure. • Worked in a group; communicated and supported other team members to establish an enhanced cooperation. • Conceived and developed systematic searching strategies for databases, including Google. • Exported data from these databases and then imported into Data Manager. • Designed data collection forms in both Word and Excel format. Extracted and managed the data. Imputed missing data. • Performed statistical analysis using Excel. Built tables in both Word and Excel, and created graphs for the output using Excel. Interpreted and summarized results. • Reported findings; gave a presentation and oral defense. Wrote the thesis
Aid for the elderly
September 2009 --- June 2010
Every Monday, Tuesday and occasionally on Friday. I took care of the elderly. My command of the Mandarin Chinese language has allowed me special access to their Chinese Dutch residents. My presence has created a more functional and communicative atmosphere between residents and staff.
Registered nurse, in-charge nurse, chief teacher
August 1997 --- March 2009
Feb. - July, 2008 Department of Oncology Project Title: The oral-pharyngeal care of NPC patients receiving radiotherapy. Academic skills obtained: methodology of randomized control trial performance, monitoring, communication, collecting data, data entry, data management, quality control audit, statistical analysis, written paper, presentation and oral defense of paper. 2008-2009, Chief teacher in the department of Oncology (In-charge Nurse) Head teacher of nursing interns and junior nurses specifically in the Oncology department – 1 year. Duties: designed and implemented the training plans, led the training staffs, invigilated clinical nursing skill exams, evaluated students’ progress that included providing both short-term and long-term feedback; evaluated and adapted teaching practices and program contents; submitted annual work plan and developed training program that included adaptation of teaching philosophies and improvement of teaching methods. Remained updated with current techniques and practices to further my own knowledge and my students’ education. 1997-2009 Worked in different departments and environments. General duties involved with implement and improve various service programs, communication with clients, student instruction, documentary administration, supplies, problem solving, meetings and maintaining standards of performance, patient care, nursing administration, medication administration, monitoring, writing patient condition reports, infection control, and helping the matron to organize and coordinate the work and nursing staffs. Negotiated relationships among patients, doctors and other medical personnel. Expertises: Oncology - 5 yrs; Obstetrics - 2 yrs; Infectious Disease - 2 yrs.; Nephropathy - 1 yr; Hematology and Endocrinology - 6 months; Neurology - 5 months; Gastroenterology - 5 months; Cardiovascular - 4 months.
Master of Science (MSc) in Clinical Epidemiology from Erasmus University Rotterdam in 2012
Bachelor's degree in Registered Nursing, Nursing Administration, Nursing Research and Clinical Nursing from BengBu Medical College, AnHui, China in 2008
Technical Secondary Diploma in Nursing from Nursing School of Anhui Medical University, Hefei, China. in 1997