Senior Regulatory Affairs Specialist

Role Summary/Purpose:

Ensure the company’s regulatory affairs activities are conducted accurately, ethically based upon relevant regulations and standards, develop and execute RA registration plan, and ensure rapid and timely approval of products.
确保公司的监管事务活动按照相关法规和标准准确道德开展，制定并执行RA注册计划，确保产品快速及时审批

Primary Responsibilities:
?Provide regulatory registration strategy for new product and change product.
?Coordinate, review, and file new device registration/approvals and amendments to existing products for market access into the Peoples Republic of China.
?Communicates with relevant competent authorities, agents, distributors, and local sales to ensure the most efficient path to application approval.
?Advise local and international teams on the most expedient route to obtaining product licenses and ensure market access strategy is aligned with local and international marketing/sales requirements.
?Participate in and advise cross-function new product/solution development teams on applications, requirements, and standards
?Review development quality reports and plans to ensure that the information required for submissions is adequate;
?Plan, generate, and coordinate regulatory submissions for product/solution licensing;
?Coordinate testing required to support regulatory submissions;
?Review and approve product/solution labeling and product/solution-related marketing communications
?Review changes in existing products to determine need for new/revised submissions or document reason for no submission.
?Maintain existing regulatory filings /Licenses, managing updates and related change control processes
?为新产品和变更产品提供监管注册策略
?协调、审查和提交新的设备注册/批准和修改现有产品，以进入中国的市场
?与相关主管当局、代理、分销商和当地销售部门进行沟通，以确保最有效的申请审批途径。
?为当地和国际团队提供获得产品许可证的最有利途径的建议，并确保市场准入策略与当地和国际市场/销售要求相一致
?参与并就应用程序、需求和标准向跨功能的新产品/解决方案开发团队提供建议
?审查开发质量报告和计划，以确保提交所需的信息足够
?计划、生成和协调产品/解决方案许可的监管提交
?协调支持监管机构提交所需的测试
?审查和批准产品/解决方案标签和与产品/解决方案相关的营销沟通
?审查现有产品的变更，以确定需要新/修订的提交或不提交的原因
?维护现有的监管文件/许可证，管理更新和相关的变更控制流程



Qualifications Education & Experience
?Bachelor’s degree or above, major in medical science, biomedical engineering or related field, safety engineering background will be preferred
?5+ years’ experience in medical device regulatory affairs, previous experience in drafting CER and submission with clinical trial data is a plus
?Have hand-on experience in assessing and successfully implementing pilot policies in GBA/BoAo and/or Innovative Medical Device Green Channel approval is a plus
?本科或以上学历，医学、生物医学工程或相关专业，安全工程背景优先
?5年上医疗器械监管经验，有起草CER和提交临床试验数据经验者优先
?有评估并成功实施GBA/BoAo和/或创新医疗器械绿色渠道批准的试点政策的亲身经验者优先


我们是谁（Mozarc Medical）:
在Mozarc Medical，我们的愿景是重新构想整体肾脏健康技术的未来。Mozarc medical成立于2023年，由肾脏护理服务提供商DaVita和美敦力共同投资，在两位长期行业和市场支持下，提供了令人兴奋的独特体验。
2023年，美敦力官宣联手透析三巨头之一DaVita正式成立了 Mozarc Meidical，新公司将专注于居家肾脏业务，公司产品涉猎透析通路和维护解决方案，急诊治疗，慢性疗法等
在使命和价值观的驱动下，我们将患者置于一切工作的中心。我们的员工在开发丰富患者生活并在肾脏疾病治疗方面取得有意义进展的技术解决方案方面发挥着关键作用。在Mozarc Medical找到你的目标和激情。