公司介紹

產業類別

聯絡人

Ivy Lai

產業描述

醫療器材法規顧問公司

電話

暫不提供

資本額

傳真

暫不提供

員工人數

10人

地址

台北市內湖區台北市內湖區成功路四段188號9樓之25


公司簡介

• Headquarted in Hong Kong, Vee Care Asia is a ISO 13485 accredited medical device regulatory consultant company. 威康有限公司 is its subsidiary in Taiwan and is now holding more than 50 foreign companies in Taiwan. • Vee Care is an ISO 13485 certified medical device regulatory consultant company providing a full range of design and compliance services to global medical manufacturers. • Founded in 2013 with sole focuses on US 510k and EU MDR regulation services, it has now grown into a one-stop shop solution provider offering design support services, quality systems set-up, technical documentation as well as product registration to key global markets. • Company Website: https://vee-med.com/

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主要商品 / 服務項目

The Company is now providing the following regulatory services to medical manufacturers. - Technical Documentation for CE / 510k - Quality System Set-up (ISO 13485 / FDA QSR/MDSAP) - License Hosting (EU/US/Taiwan/ASEAN) - Product Validation Services - Biocompatibility Tests (ISO 10993 Series) - Electrical Safety Test (IEC/AMI 60601 Series)

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福利制度

法定項目

其他福利

工作機會

工作性質
廠商排序
9/30
台北市內湖區2年以上大學以上待遇面議
We are looking for an energetic person to join our rapidly growing regulatory consultant team. The company will offer comprehensive trainings, both internal and external, for this trainee position. Successful personnel shall be able to handle either quality system or technical projects independently in 2-3 years' time. <Role Descriptions> •Prepare high quality documentation for medical device customers to ensure timely submissions of new registrations, variations, and renewals to ensure compliance with regulatory requirements and legal obligations. •Conduct gap analysis on customers' existing regulatory dossiers and provide the required support advice as needed. •Communicating with government agencies regularly to manage the application status. •Research through different resources to the latest regulatory requirements. <Industry> Management Consulting/Medical Devices
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