协助项目组及产品经理评审确定产品全球（除中国外）上市的法规要求； 根据信息输入，编写整理并提供国际注册（主要是CE，FDA及客户当地注册）所需的资料； 跟踪产品检测/注册/认证的进度，确保按进度完成； 负责CE技术文件的适时更新； 根据客户要求，办理文书公证； 维护国际注册/认证产品清单； 收集更新各地区的注册认证相关法规。...

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com. The genomics division designs and develops state of the art, cutting edge, geneti...

Locations Tempe, Arizona Job Description Summary Job Description This position is responsible for the development and implementation of product registration dossiers in support of applications in US, China, Taiwan, and Hong Kong. The candidate will be expected to compose, review, and summarize product technical data that is required by regulatory agencies to demonstrate compliance with global regulations and standards. The candidate will be expected to interface and communicate effectively with ...

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do.  A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. Job Description Join our international team and support regulatory aspects of clinical research projects, streamlining communic...

Job Description Summary This position is responsible for the development and implementation of product registration dossiers in support of applications in China, Taiwan, and Hong Kong. The candidate will be expected to compose, review, and summarize product technical data that is required by regulatory agencies to demonstrate compliance with global regulations and standards. The candidate will be expected to interface and communicate effectively with international business colleagues and regulat...

Position Purpose Regulatory Affairs Manager is responsible for the plan and implementation of product registration, maintaining the approved product licenses and coordinating regulatory Affairs activities in compliance with Health Authority’s regulations and Company’s Standard Operating Procedures (SOPs). She (he) needs to liaise with Pfizer colleagues for supports and guidance. She (he) should keep good relationship with the regulatory authority, provide knowledge and experience to junior colle...

Job Description Summary This position will provide Regulatory Affairs (RA) support for product remediation projects, process and systems remediation projects, and the preparation of regulatory submissions required to legally market medical devices in the European Union under the MDR. This role will provide support for global product registrations and related regulatory affairs activities, as required. This role will appropriately execute project activities based on applicable products and system...

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. How will you make an impact? The Regulatory Affairs Specialist is responsible for assisting in preparation, implementation, conformance and verification of Company quality poli...

Role Summary: This position provides subject matter guidance. He/she works within a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in compliance with regulatory requirements. The Regulatory Affairs Leader will be involved with regulatory activities in the areas such as premarket submissions, post-market reporting, regulatory intelligence, regulatory requirements flow-down advertising and promotion review, product labeling compliance, etc., Essential Responsibi...

The Job: Opportunity for a career in regulatory affairs in the pharmaceutical Industry. This involves assisting our company Pharmacist and Management to:   contact our overseas pharmaceutical suppliers prepare documentations for product registration with the Department of Health meet various compliance requirements specified by the Government prepare marketing materials to promote various new products   The Requirements: Tertiary education with a science-related discipline preferred Good in Engl...

Principal Responsibility Ensure all existing and new drug products comply with the updated China authority requirement and registration approval timely. Maintain current marketed drug product license & approval and enhance drug products variation application registration and approval in terms of business needs Prepare and submit registration dossier and deficiency response timely in terms of company internal data and comply with China regulatory requirement and guideline. Lead regulatory lon...

About Us Founded in America by Professor Beckman and the Coulter brothers, Beckman Coulter Limited is dedicated to the to the development and sale of instruments, reagents, software and products that simplify and automate laboratory processing that are widely used in hospitals, clinics, and commercial laboratories worldwide. Clinical diagnostic tools implemented within company products include: laboratory automation systems, biochemical analytical systems, immunoassay systems, hematology systems...

For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Job Description *Essential Duties and Job Functions: Responsible for maintaining the necessary licenses. Responsible for preparing regulatory submissions which require interactions with other functions for investigational and commercial products in line with ICH requirements, Taiwan requirements and scientific and company policies and procedures. Responsible for submissions which may in...

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries. This position is responsible for planning, creating and implementing solutions for regulatory approvals of products. Job Duties : • Manages the Regula...

Job Title Regulatory Affairs Engineer Job Description In this role, you have the opportunity to Know customer needs and regulatory requirement of medical device; Familiar with advanced product development process and QMS; Be expert of product certification; Handle the regulatory affairs in Shenzhen facility, ensure NMPA regulatory compliance. You are responsible for Register SRC Shenzhen products to NMPA, responsible for registration strategy and process design, registration file preparation, re...

About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com....

About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com....

About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com....

About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com....

About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com....