【北京 Regulatory Affairs Specialist招聘】-丹纳赫北京招聘信息-猎聘

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职位介绍: • Job Description Summary Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on product recalls. Respond to regulatory agency inquiries. Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements. • Job Description FUNCTION: This position will have responsibility to: • Submit product registration dossier and get approval according to the registration plan, with compliance to regulations and SOP. • Execute product registration strategy plans in China/US/EU/Other target markets. • Follow up and interpret Global MD, IVD related regulation updates. • Establish and maintain good relationship with key contacts such as type testing centers, NMPA and its affiliated organizations. ESSENTIAL DUTIES AND RESPONSIBILITIES: The incumbent will also be responsible for, but not limiting to the following duties: • Complete overseas registration cases and get product certificates according to registration plan. • Maintain submission documents and approval documents in related IT systems. • Provide the regulatory support to cross-functional team within and outside China. • Provide necessary support to dealers and customers for regulatory compliance. • Collect, analysis the new released regulations globally. This description is a summary of principle responsibilities and is not intended to include all duties may be assigned. WORKING RELATIONSHIPS AND CONTACTS: • External contacts for this position include NMPA officials / Overseas health authority officials, dealers and users/customers, local testing center, • Internal contacts include headquarter, marketing team, logistic team, application and sales/service team, QA, R&D. ESSENTIAL QUALIFICATIONS: EDUCATION & SKILLS: • Bachelor degree or above. • Medicine / bioengineering / clinical medicine / biochemistry or pharmacy relevant background is preferred. • Good English and Chinese language skills WORKING EXPERIENCE: This position requires: • 2 years or above RA working experience in IVD industry. • Preferably China MD and IVD registration experiences. FUNCTIONAL COMPETENCIES: • Expertise in NMPA regulation of IVD and/or medical devices and in NMPA registration process; • Excellent teamwork and interpersonal communication skill; • Good attitude, positive thinking & take responsibility; • Creative thinking for complexed registration cases. TRAVEL REQUIREMENTS: This position may require business traveling in a fewness situation. WORK ENVIRONMENT: This position functions in a general office environment.

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公司简介

在丹纳赫，我们汇集科学、技术和运营的能力，让未来科技对今日生活的影响得以加速实现。我们携手全球客户，构建方案，解决他们最为复杂的挑战，将科学的力量变为现实。我们的全球团队正在创造生命科学、医学诊断、生物技术等领域的未来。了解更多信息，请访问 www.danaher.com 。 At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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