At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised. **What You Can Expect** Responsible for managing all facets of quality assurance support and quality system processes for Zimmer Biomet Taiwan. This includes ensuring compliance with the corporate requirements, TFDA regulations, ISO 13485 Quality System Standard and other applicable regulations. Able to lead quality improvement projects and resolves problems that have implications beyond own area of responsibility. Require professional expertise and interpersonal skills to manage multiple projects. **How You'll Create Impact** + Compile and submit new product registrations, QSD registrations, license extensions, variations, and renewal according to the submission plan, and ensure approvals in a timely manner. Maintain and archive regulatory files in a format consistent with requirements. + Provide regulatory support to internal/external customers. + Assist and work with logistics to maintain the logistic-RA related database, procedures and systems. + Support to maintain regulatory database in GTS, SAP systems. Support to maintain the UDI information to TFDA TUDID. + Support to maintain the Chinese labelling database and Chinese labelling activities. + Support the product complaints handling, AE, quality field actions, recalls and PMS data collection or reporting in Taiwan. + Support to mapping the latest regulatory and corporate requirements concerning quality and quality systems. Update the necessary processes and procedures for Taiwan. + Support to maintain ISO 13485, QMS, GDP quality system. **Your Background** + Bachelors' degree or above (life sciences or equivalent field is preferred). + 2-3 years RA or QA work experiences in multinational medical device or pharmaceutical companies. + Good command of the English and Chinese languages (speaking, reading and writing) + Knowledge of ISO 13485, QMS and GDP. + Superior interpersonal and communication skills + Proactive in taking initiative and prioritizing pipeline projects + Good computer skills (Microsoft Office, Winchill etc.) + Responsible, professional, detail oriented and with patience EOE/M/F/Vet/Disability