Sr. Officer, Regulatory Affairs,SH 25-30k·14薪
上海-长宁区 5-10年 统招本科 招1人 今日更新
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职位介绍
3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You’ll Make in this Role In this position of senior officer, regulatory affairs, you will have the opportunity to act as the lead for regulatory affairs on cross functional teams and have ownership of product line submissions, registrations and QMS audits in China NMPA, for the Dental Solutions business. The position will work with the international regulatory affairs group to ensure products are registered based on the business strategy. In addition, you will have the opportunity to support labeling and registration changes to due the company spin-off. As a(n) Senior Officer, Regulatory Affairs, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: ● Leading & conducting NPI projects registrations for imported and localized medical devices. ● Conducting regulatory change assessments and coordinating associated. ● Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality in addition to excellent organizational, prioritization, oral and written communication skills. ● Providing regulatory review of technical reports, BER, CER and documents. ● Providing contributions for development and implementation of regulatory processes. ● Documenting and managing metrics. ● Leading regulatory filings as needed for assigned projects. ● Supporting risk management activities, vigilance reporting activities, and other quality related initiatives with minimal oversight. ● Leading the implementation of key corporate initiatives and appropriate tools. The job also requires performing other duties as assigned. Percentages of time spent on job duties are estimates and may vary for each position. A successful candidate for this role: ● Possesses thorough understanding of concepts and professional practices to solve complex and diverse regulatory problems. ● Has exceptional attention to detail, written and oral communication skills. ● Utilizes strong technical and non-technical communication skills of listening, reading, writing, and speaking and continuously improves upon these skills through regular participation in appropriate training activities. ● Maintains broad knowledge of assigned organization's products, broad industry trends, and customer needs. ● Capable of developing understanding of technologies and/or products across multiple divisions. ● Possesses knowledge of and regularly utilizes available information resources and systems. ● Collaborates with colleagues to innovate, influence, and/or negotiate when required. Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications: ● Bachelor’s Degree or higher from an accredited university such as Biology, Chemistry, Biomedical Engineering or a related technical/health care field. ● 8+ years in regulatory affairs in the medical device industry. ● Direct experience authoring submissions/technical documentation for imported and localized medical devices. ● Direct experience authoring regulatory strategies, regulatory change assessments and gap analysis. ● Direct experience revising, reviewing and approving labeling (including marketing claims) that meet regulatory requirements. ● Must have experience and expertise in design control verification and validation activities, as well as expertise in CER requirements for medical devices; in particular, experience with assisting teams with documenting and performing to applicable requirements, and assisting with writing, reviewing and approving all protocols and reports. ● Expert Chinese and English technical writing capabilities. ● Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devices, proficient in Office Suite Work location: Maxdo, Shanghai,Onsite Travel: Subject to job requirements Supporting Your Well-being Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. global job description.
其他信息
行业要求:医疗器械

公司简介

舒万诺公司,原3M 医疗健康业务,于2024年4月正式完成从3M的拆分并在纽交所上市,成为独立的全球性医疗健康公司。舒万诺专注于解决重大医疗健康挑战,其全球总部位于美国明尼苏达州的圣保罗市。 我们是一家有着70多年历史的新公司。70多年来,我们提供突破性解决方案,解决客户面临的严峻的医疗健康挑战,深受客户信赖。舒万诺全新成立后,我们将继续秉承倾听和创新这一传承,致力于实现更好、更高效、更安全的医疗健康,从而改善人们的生活。 我们的解决方案涵盖医疗外科、齿科解决方案、净化及过滤、健康信息系统四大业务领域。2023 年,在舒万诺仍隶属于 3M 时,我们的业务销售额就达到了 82 亿美元。我们在健康、材料和数据科学的交叉领域创新突破,致力于开发改善患者生活的解决方案,同时协助医疗专业人员更高效地帮助患者。人们及其健康福祉是我们追求的每一项科学进步的核心所在。 我们的全球影响力:我们拥有超过 22,000 名员工,分布在全球 300 多个办公室和工厂,为 90 多个国家和地区的客户提供服务。我们在全球拥有超过 7,300 项专利的自主知识产权,以及由 2,100 多名专家和技术人员组成的全球研发团队。我们在12个国家设立了24个生产基地,并且与全球超过 100,000 个渠道合作伙伴建立了合作关系。 我们在中国的足迹:舒万诺在中国的发展可以追溯到上世纪80年代。目前,我们在中国拥有1,000多名员工,业务遍布全国。我们在中国布局了1个商业总部,1个研发中心,2个技术中心, 2个工厂和 3个物流中心。 我们是舒万诺。我们步履不止,为您所需!
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更新时间:2026-08-16