招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
语言要求：
英语
Major Accountabilities
? Responsible for regulatory plans, submission, and approval of clinical trial and marketing authorization applications for all IOL new products and life cycle management of marketed products in China, aligned with Global Regulatory and Region and Country business strategies and plans.
? Monitor operational progression of pre-marketing authorization activities at country level through contact with country regulatory agencies or committees, as required.
? Good communication with the country regulatory agencies or committees to expedite new marketing authorization approvals and other operational regulatory interventions.
? Ensures all documents submitted to regulatory agencies are complete, well organized, in regulatory compliance, and presented in a manner that facilitates agency review.
? Responsible for maintaining records of regulatory submissions and communications with the relevant regulatory agencies.
? Work with commercial colleagues to develop promotional strategies and provide regulatory review for promotional materials for IOL products.
? Develop and maintain excellent working relationships with health authorities; identify regulatory risks for investigational and marketed products and develop strategies to minimize those risks.
? Monitor and provide regulatory intelligence on new medical device legislation, guidance and policy proposals impacting Alcon’s IOL products or processes. Provide regulatory intelligence on competitive products and companies.
?Accountable for ensuring Alcon is adequately represented in relevant regulatory advocacy groups, to ensure the company position is considered as new IOL regulations are proposed by health authorities.
Background
Education : Bachelor’s degree in a related field is required.
Experience:
At least 6 years in Regulatory Affairs, with significant depth of experience within the medical device industry
A track record of successful execution of regulatory submissions and approvals for medical devices
High energy, collaborative and experience initiating and leading change
Ability to influence senior stakeholders in a global environment
年薪20-30万
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