RA specialist （伴随诊断）
安捷伦科技有限公司Agilent Technologies Co., Ltd.
- 公司规模：500-1000人
- 公司性质：外资(欧美)
- 公司行业：电子技术/半导体/集成电路
职位信息
- 发布日期：2021-06-04
- 工作地点：北京-朝阳区
- 招聘人数：1人
- 工作经验：无需经验
- 学历要求：本科
- 职位月薪：20-30万/年
- 职位类别：药品注册 医疗器械注册
职位描述
This position will be part of the Companion Diagnostics Regulatory Affairs team, reporting directly to the Companion Diagnostics regulatory affairs manager in China. This person will provide both strategic and operational support to ensure proper regulatory submissions, registrations, licenses and approvals in China. We are looking for a highly motivated and experienced Regulatory Affairs professional to join our Agilent team working within the Companion Diagnostics business. The role will work as individual contributor and be based in Agilent Beijing Campus. The person will also need to work efficiently with global R&D, manufacturing and other functions such as local commercial division. The preferred candidate would have experience in IVD and be familiar with Companion Diagnostics, and interactions with CNDA. The candidate must have good oral and written communication skills. The candidate will represent Regulatory Affairs on project teams and in close collaboration with pharmaceutical partners. Responsibilities *Plan, provide regulatory guidance, coordinate and manage the day-to-day CNDA pre-market approval submissions for Companion Diagnostics (CDx) and obtain approval of premarket product registration timely. *Inform other business units about changing regulations in IVDs and Companion diagnostics in China. *Interact with CNDA on registration requirements and monitor changes to requirements. *Independently manages and provide regulatory guidance to short-term and long-term projects. *Works directly with pharma companies in China. Internal Qualifications: * University degree or above in a technical discipline (bio-engineering, chemical, biology, laboratory diagnosis, pharmaceutical preferred) *A minimum of 3 years of RA experience in IVD or medical device field. *Strong skills in regulatory strategy and planning, preferably with in vitro diagnostics *Experience working directly with CNDA *Strong decision-making skills *Experience working in projects as part of project teams *Capability of working in multiple project teams in parallel and a sense-of-urgency in meeting deliverables and project requirements. *Knowledge of pathology and oncology is preferred * Personal competencies *Advanced skills in English both written and spoken *Ability to communicate (oral/written) and interact effectively across all levels, disciplines, and countries, particularly with regulators and standard committee members. This position will be part of the Companion Diagnostics Regulatory Affairs team, reporting directly to the Companion Diagnostics regulatory affairs manager in China. This person will provide both strategic and operational support to ensure proper regulatory submissions, registrations, licenses and approvals in China. We are looking for a highly motivated and experienced Regulatory Affairs professional to join our Agilent team working within the Companion Diagnostics business. The role will work as individual contributor and be based in Agilent Beijing Campus. The person will also need to work efficiently with global R&D, manufacturing and other functions such as local commercial division. The preferred candidate would have experience in IVD and be familiar with Companion Diagnostics, and interactions with CNDA. The candidate must have good oral and written communication skills. The candidate will represent Regulatory Affairs on project teams and in close collaboration with pharmaceutical partners. Responsibilities *Plan, provide regulatory guidance, coordinate and manage the day-to-day CNDA pre-market approval submissions for Companion Diagnostics (CDx) and obtain approval of premarket product registration timely. *Inform other business units about changing regulations in IVDs and Companion diagnostics in China. *Interact with CNDA on registration requirements and monitor changes to requirements. *Independently manages and provide regulatory guidance to short-term and long-term projects. *Works directly with pharma companies in China. Internal Qualifications: * University degree or above in a technical discipline (bio-engineering, chemical, biology, laboratory diagnosis, pharmaceutical preferred) *A minimum of 3 years of RA experience in IVD or medical device field. *Strong skills in regulatory strategy and planning, preferably with in vitro diagnostics *Experience working directly with CNDA *Strong decision-making skills *Experience working in projects as part of project teams *Capability of working in multiple project teams in parallel and a sense-of-urgency in meeting deliverables and project requirements. *Knowledge of pathology and oncology is preferred * Personal competencies *Advanced skills in English both written and spoken *Ability to communicate (oral/written) and interact effectively across all levels, disciplines, and countries, particularly with regulators and standard committee members.
Requirements:
* University degree or above in a technical discipline (bioengineering, chemical, biology, laboratory diagnosis, pharmaceutical preferred)
*A minimum of 3 years of RA experience in IVD or medical device field.
*Strong skills in regulatory strategy and planning, preferably with in vitro diagnostics
*Experience working directly with CNDA
*Strong decision-making skills
*Experience working in projects as part of project teams
*Capability of working in multiple project teams in parallel and a sense-of-urgency in meeting deliverables and project requirements.
*Knowledge of pathology and oncology is preferred
*Personal competencies
*Advanced skills in English both written and spoken
*Ability to communicate (oral/written) and interact effectively across all levels, disciplines, and countries, particularly with regulators and standard committee members.
公司介绍
Agilent is a leader in life sciences, diagnostics and applied chemical markets. The company provides laboratories worldwide with instruments, services, consumables, applications and expertise, enabling customers to gain the insights they seek. Agilent’s expertise and trusted collaboration give them the highest confidence in our solutions.
Agilent focuses its expertise on six key markets, where we help our customers achieve their goals:
Food: Agilent helps ensure that our global food supply is free of contaminants—whether chemical, viral, bacterial or microbiological. Our customers include government regulators and labs that control food safety, as well as private companies that produce, package and sell food to the public.
Environmental and Forensics: From pesticides to pharmaceutical residues to trace metals, we provide fast, accurate and sensitive methods for monitoring contaminants affecting quality of life. Agilent solutions also play an important role in law enforcement by providing robust tools and instruments to analyze and verify evidence at trial, and keeping the world’s top-performing athletes honest.
Pharmaceutical: Agilent has one of the broadest solutions portfolios of any company serving the pharmaceutical industry. Our solutions provide precise answers for every segment of the pharmaceutical industry, from disease research and drug discovery to drug development, manufacturing and quality control. The start-to-finish solution set means customers can get products to market faster. Customers trust us to help them test the purity of their therapeutics. Agilent also ensures that their instruments and processes conform to the highest compliance regulations.
Diagnostics: Agilent gives doctors a head start in the fight against cancer and other diseases. Our solutions help pathology laboratories deliver fast, accurate information to the doctors, hospitals and medical centers they serve. We help medical professionals make more accurate diagnoses so patients can receive the most effective therapies.
Chemical and Energy: The world runs on energy, and energy companies need to locate, extract and refine fuels efficiently and cost-effectively. Our solutions help customers maximize their production and predict failures in their refineries before they happen. Agilent also helps energy researchers investigate biofuels, renewable fuels and other forms of alternate energy.
Research: Most life sciences and diagnostics research is done at top-tier universities, with funding from governments around the world. Agilent is helping these researchers learn more about cancer, cardiovascular diseases, diabetes, Alzheimer’s, Parkinson’s, autism and other ailments. Our instruments, software and sample preparation solutions help scientists conduct faster, more accurate research.
AGILENT RESEARCH LABORATORIES
The purpose of Agilent Research Laboratories is to power Agilent’s growth through breakthrough science and technology.
To complement our product line R&D, Agilent Labs looks beyond the evolution of current products and platforms to create the technologies that will underlie tomorrow’s breakthroughs, enabling Agilent customers to answer questions at the leading edge of life science, diagnostics and the applied markets. Our horizon is broad, encompassing synergies across Agilent and seeding new businesses to create competitive differentiation and compelling value for current and future customers and shareholders.
To accomplish these goals, we attract and retain top technical talent, collaborate extensively with global research leaders in academia, government and industry, and promote a culture of innovation and teamwork across our highly multi-disciplinary staff of life scientists, physical scientists and engineers. The majority of our research is located in the United States in Santa Clara, California, with additional locations in Europe and Asia.
Agilent focuses its expertise on six key markets, where we help our customers achieve their goals:
Food: Agilent helps ensure that our global food supply is free of contaminants—whether chemical, viral, bacterial or microbiological. Our customers include government regulators and labs that control food safety, as well as private companies that produce, package and sell food to the public.
Environmental and Forensics: From pesticides to pharmaceutical residues to trace metals, we provide fast, accurate and sensitive methods for monitoring contaminants affecting quality of life. Agilent solutions also play an important role in law enforcement by providing robust tools and instruments to analyze and verify evidence at trial, and keeping the world’s top-performing athletes honest.
Pharmaceutical: Agilent has one of the broadest solutions portfolios of any company serving the pharmaceutical industry. Our solutions provide precise answers for every segment of the pharmaceutical industry, from disease research and drug discovery to drug development, manufacturing and quality control. The start-to-finish solution set means customers can get products to market faster. Customers trust us to help them test the purity of their therapeutics. Agilent also ensures that their instruments and processes conform to the highest compliance regulations.
Diagnostics: Agilent gives doctors a head start in the fight against cancer and other diseases. Our solutions help pathology laboratories deliver fast, accurate information to the doctors, hospitals and medical centers they serve. We help medical professionals make more accurate diagnoses so patients can receive the most effective therapies.
Chemical and Energy: The world runs on energy, and energy companies need to locate, extract and refine fuels efficiently and cost-effectively. Our solutions help customers maximize their production and predict failures in their refineries before they happen. Agilent also helps energy researchers investigate biofuels, renewable fuels and other forms of alternate energy.
Research: Most life sciences and diagnostics research is done at top-tier universities, with funding from governments around the world. Agilent is helping these researchers learn more about cancer, cardiovascular diseases, diabetes, Alzheimer’s, Parkinson’s, autism and other ailments. Our instruments, software and sample preparation solutions help scientists conduct faster, more accurate research.
AGILENT RESEARCH LABORATORIES
The purpose of Agilent Research Laboratories is to power Agilent’s growth through breakthrough science and technology.
To complement our product line R&D, Agilent Labs looks beyond the evolution of current products and platforms to create the technologies that will underlie tomorrow’s breakthroughs, enabling Agilent customers to answer questions at the leading edge of life science, diagnostics and the applied markets. Our horizon is broad, encompassing synergies across Agilent and seeding new businesses to create competitive differentiation and compelling value for current and future customers and shareholders.
To accomplish these goals, we attract and retain top technical talent, collaborate extensively with global research leaders in academia, government and industry, and promote a culture of innovation and teamwork across our highly multi-disciplinary staff of life scientists, physical scientists and engineers. The majority of our research is located in the United States in Santa Clara, California, with additional locations in Europe and Asia.
联系方式
- Email：dustin.zhou@non.agilent.com
- 公司地址：0 (邮编：000000)
- 电话：15801223711