Key Responsibilities:
主要职责：
Responsibilities and essential job functions includes but not limited to the following:
工作职责和职能包括但不限于以下：
1. Execute Technical File assessments as a product reviewer on active medical devices according to regulation (e.g. MDR and MDD), common specification and standard requirements.
作为有源医疗器械产品审核员，按照法规（如MDR及MDD）、标准、程序及行为准则审查客户技术文件；
2. Maintain and develop skills in the field of standard, regulation, medical device (e.g. familiar with the product knowledge and standard requirements, follow the latest standard and regulation). 保持和提升在标准、法规、医疗器械产品方面的技能（例如：熟悉专业领域的产品知识及标准要求、跟踪标准法规的最新动态
3. Responsible for the on-site audit, periodical Technical Files assessments, State of the art reviews and the Vigilance and Change Notifications of your customer.
负责客户的现场审查，定期技术文件审核，为客户定期和不定期进行法规和标准查新，识别风险。
4. Maintain contact with the customer concerning the Product review outcome and required follow up.
与客户保持密切沟通，时刻关注产品审核结果和审核要求。
5. Maintain contact with our Italian Headquarter colleagues, external experts and contractors.
与意大利总部团队、外部专家及第三方人员保持沟通，
6. Provide the audit team with expert input and write test plans for unannounced audits.
为审核团队提供专业支持，为不通知的审核撰写测试计划。
7. Will work at the company office.
需要坐班。

Skills:
技能：
1. At least bachelor’s degree with diploma in active medical device related major (e.g. Biomedical Engineering, Electronic Engineering, Automatic Control，computer science).
本科及以上学历，有源医疗器械相关专业（例如，生物医学工程、电子工程、自动控制、计算机科学等）
2. At least 4 years of professional experience in the field of active medical devices such as manufacturing, auditing or research of which at least 2 years in the design, manufacture, and testing of Medical Devices.
至少4年有源医疗器械领域工作经验，如医疗器械生产、验证或研发工作经验，其中，至少有2年研发/生产/测试经验。
3.Experience in the field of medical device software, monitoring, imaging devices is preferable.
医疗器械软件、监护设备、成像设备经验优先
4. Work experience with medical device standards/regulation (e.g. ISO 13485, ISO 14971, IEC 60601-1, MDD or MDR) is preferable.
具有医疗器械标准法规经验（例如，ISO 13485, ISO 14971, IEC 60601-1, MDD 或 MDR）优先。
5. ISO 13485 qualification is preferable.
具有ISO 13485审核员资质优先；
6. CCAA qualification is preferable
具有CCAA注册审核员资格优先；
7. English language skills are required.
英语需要能作为工作语言。