【上海 Clinical Development Expert (IVD & Medical Devices)招聘】-猎头顾问上海招聘信息-猎聘

杨先生 2天前在线已认证

顾问 · 上海必胜人力资源有限公司

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职位介绍: About the Opportunity Our client, a leading global healthcare and diagnostics organization, is seeking an experienced Clinical Development Expert to support the clinical development and registration of innovative in-vitro diagnostics (IVD), medical devices, and related software products in China. This role will be responsible for developing clinical strategies, designing and managing clinical studies, driving regulatory interactions, and coordinating cross-functional teams to ensure successful product registrations and market access. The successful candidate will have the opportunity to contribute to the localization and regulatory approval of cutting-edge healthcare technologies. Key Responsibilities Clinical Strategy & Regulatory Support Develop optimal clinical development strategies and clinical evaluation pathways for products intended for regulatory registration. Assess clinical evidence requirements and identify the most effective registration approach. Evaluate project timelines, resource requirements, and budget estimates. Monitor regulatory developments and assess their impact on ongoing and future projects. Clinical Study Design & Execution Independently develop scientifically robust and regulatory-compliant clinical study protocols. Design clinical study plans based on product characteristics, regulatory guidance, clinical practice guidelines, and expert consensus. Establish realistic study timelines and oversee project execution. Ensure studies are conducted in compliance with applicable regulations, quality standards, and company procedures. Risk Management & Problem Solving Proactively identify operational, regulatory, and scientific risks throughout the project lifecycle. Develop mitigation plans and drive effective risk management actions. Resolve complex project issues through structured analysis and stakeholder collaboration. Ensure successful delivery of clinical development objectives. Regulatory Agency Interaction Maintain effective communication with relevant regulatory authorities and review agencies. Support technical discussions and regulatory evaluations throughout the registration process. Coordinate responses to deficiency letters, review comments, and supplemental information requests. Facilitate timely issue resolution to support successful product approvals. Project Leadership & Cross-Functional Collaboration Lead clinical development projects and coordinate activities across Regulatory Affairs, Medical Affairs, R&D, Quality, Marketing, and other functions. Leverage both internal and external resources to achieve project goals. Build strong collaboration with investigators, key opinion leaders (KOLs), and research institutions. Establish effective communication mechanisms to maintain alignment among stakeholders. Additional Responsibilities Represent the company as the primary contact for assigned projects when required. Support strategic and cross-functional business initiatives. Complete additional assignments delegated by management. Ensure full compliance with applicable quality, compliance, ethical, safety, and environmental requirements. Qualifications Education Bachelor’s degree or above in a medical, healthcare, or life sciences discipline, preferably: Clinical Medicine Medical Laboratory Science Biology Biochemistry Pharmacy Biomedical Engineering Other related Life Science disciplines Experience Minimum 5 years of experience in Clinical Research, Clinical Development, Clinical Project Management, Clinical Data Management, or related fields. Experience in one or more of the following industries: In Vitro Diagnostics (IVD) Medical Devices Pharmaceutical Industry Contract Research Organizations (CROs) Clinical Research Institutions Previous experience supporting registration clinical studies is highly preferred. Experience with innovative products, market authorization projects, or regulatory-focused clinical programs is a strong advantage. Technical & Professional Skills Solid understanding of Chinese medical device and/or IVD regulatory requirements. Familiarity with ICH-GCP and applicable clinical research regulations. Ability to independently develop clinical evaluation strategies and study protocols. Strong project management and risk assessment capabilities. Proven ability to analyze complex situations and develop effective solutions. Knowledge of clinical trial processes, clinical evidence generation, and product registration pathways.

其他信息: 语言要求：普通话 + 英语; 行业要求：医疗器械

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