Assistant Regulatory Affairs Manager

Job Description1. Maintain Quality Management System, Certification and Registration in compliance to regulatory requirement (ISO9001, ISO13485, US FDA, cGMP)2. Product registration in US, UK, Japan, Singapore, and other countries3. Environmental control, monitoring and reporting, not limited to cleanroom air/surface microbial, temperature & humidity, particle count, product bioburden, 3rd party certification, PEST control, LAL testing.4. Manages failure investigations, including customer complaints and non-conforming events, and implementation of effective preventive and corrective actions.5. Manages sterilization, transportation, stability, biocompatibility, and product release activities6. Maintain current regulatory affairs and technical knowledge and perform gap analysis and QMS system implementation and training to staff for compliance7. Maintain library of product and process-related reference standards, regulations, guidance’s, clinical articles.8. Guidance in risk management review & approval, develop risk management strategies & approaches.9. Report FDA advisory notice and MDR10. Lead 8S program and maintain good 5S housekeeping and safety at workplace11. Drive Operational Excellence program in continiuos improvement12. Perform any other duties as assigned from time to timeJob RequirementMinimum 3 years experience in either domestic and regional regulatory affairs in medical device industry, preferably molding industry.Familiar in QC Tools, FMEA, SPC, Poka YokeKnowledge in Sterilization, Micro-lab, bioburden and endotoxins test will be added advantageCertified Internal Auditor, 6 sigma trainedTeam playerGood communication skillsGood analytical and problem solving skillsGood eyesight, Proficient in English and Chinese, both veral and written