Director Quality and Regulatory Compliance, Eastern Asia
3 months ago
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview 工作概述
The Director of QRC, East Asia will serve as an active member of the Global Sales (GS) QRC leadership and East Asia Region Leadership Teams, on top of the role as Regional Management Representative. He/ She will provide Regulatory & Quality Leadership for the East Asia (EA) region, including China, Hong Kong, Taiwan, Macau and Mongolia where Getinge is present.
The incumbent is expected to have good understanding of the EA region country’s QA & RA requirements and is also expected to lead activities to bridge gaps in the QMS & product registration requirements. Managing and insuring proper filing of all required compliance documents, submissions, registrations, etc.
This role will have a solid line reporting to Senior QRC Director, APAC & dotted reporting to the President, Eastern Asia.
Job Responsibilities and Essential Duties 工作职责和基本职责
A list of the main responsibilities and percentage of time spent in each responsibility or group of responsibilities: 主要职责以及每一职责或一组职责所占时间百分比清单：
Regulatory Affairs (RA)
Work closely and virtually managing the East Asia QRC teams, including China, Taiwan, Hong Kong, and overseeing their operations of RA activities. Work with the Country Managing Directors and Business Leaders to establish and execute the regulatory strategy to support business growth in each Sales & Service Unit (SSU). Work closely with Getinge Product Area (PA) RA Team to plan, manage, coordinate and execute the regulatory submissions for products within the Region according to the approved product registration priorities including new products, renewals, and product changes. Manage and provide guidance to RA Teams in handling responses from country registration authorities. Develop content, timelines and contingencies plan for submissions in collaboration with internal stakeholders, if required. Direct the development of regulatory systems, practices and processes to ensure compliant to the respective local regulations while maintaining alignment with Global Quality Management System Establish a central depository database system in EA for the compilation of submission documents, tracking of submissions, license numbers and approvals dates, and response to question preparation for all countries in EA region. All RA related documents should be properly categorized in the database.Quality Assurance (QA)
Responsible for developing, implementing, and maintaining necessary quality programme to ensure compliance with all requisite regulatory agencies in EA region. Strong knowledge of the good manufacturing practices (GMP) / Good Distribution Practices for Medical Device (GDPMD) regulations. Integrating and harmonizing Global Sales QMS processes and procedures in all areas of Quality Assurance/ Regulatory Affairs, including, but not limited to, Post Market Surveillance, Auditing, and CAPA processing. Ensuring all authority reporting activities such as post market surveillance, field action etc are completed & submitted on timely manner. Contribute to the development of high-quality systems and products by ensuring functionality meets documented specifications, product requirements and organizational goals. Educate internal stakeholders across the organization regarding the quality function and their role in ensuring quality standards are met. Actively monitor regulatory changes and communicate relevant topics to PA QA/RA for support in planning and implementation to ensure regulatory compliance. Support Establishing, Maintaining and improving Global Sales QMS to meet ISO13485 and/or local regulations on medical device. Report on QMS effectiveness and requirements to local management team as require, including preparing and executing Quality Management Reviews. Chairing the monthly KPI review of site quality objectives, metrics, reporting and operating mechanisms. Assume the role of "Quality Principal" for SSU China. This role is required by China NMPA regulation.Minimum Requirements 任职条件
Each organization shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed and shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. Bachelor's degree in science or Engineering discipline. Minimum 15 years related experience in Quality and Regulatory Affairs management in Medical Device company preferred. Strong knowledge and experience in global and local quality requirements, with an emphasis on China NMPA Successful interactions with global Quality team and local authorities Good knowledge of supervisory/ management experience, including hiring. training, coaching and performance management activities.Required Knowledge, Skills and Abilities 所需的知识、技能和能力
Advanced understanding of regulatory framework and regulatory requirements for East Asia region English fluent & mandarin required for Greater China market. Internal and external communication and collaboration skills. Advanced written communication skills; ability to communicate clearly and concisely with business and technical stakeholders. Ability to work collaboratively and effectively across matrix organizations in a fast-paced organization. Ability to leverage business, product and functional requirements to create test plans and test cases. Knowledge of product lifecycle. Knowledge of global business/ organizational activities. Ability to lead, develop, and effectively manage employees operating in a Region. Strong interpersonal relationship building and employee coaching/ development skills.About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
-
Changning District, China Maquet (Shanghai) Medical Equipment Co., Full timeAbout the RoleWe are seeking a highly skilled Director of Quality and Regulatory Compliance for our East Asia region. This role will be responsible for providing regulatory and quality leadership for our operations in China, Hong Kong, Taiwan, Macau, and Mongolia.Key ResponsibilitiesWork closely with our East Asia QRC teams to ensure compliance with...
-
Changning District, China Maquet (Shanghai) Medical Equipment Co., Full timeJob DescriptionWe are seeking a seasoned professional to fill the role of Global Quality and Regulatory Affairs Leader in East Asia, based in Shanghai, China. As part of our commitment to excellence, this individual will lead our quality and regulatory affairs efforts in the region.About the RoleThis is an exciting opportunity for a talented and experienced...
-
Changning District, China Maquet (Shanghai) Medical Equipment Co., Full timeWe are seeking a seasoned Marketing Director to lead our efforts in the medical device solutions space.About the RoleThis is an exceptional opportunity to join a dynamic team and contribute to the development of innovative marketing strategies that drive business growth and success.Key Responsibilities:Develop and execute comprehensive marketing plans to...
-
(Sr.) Manager, Regulatory Affairs-CMC
6 months ago
Daxing District, China AstraZeneca Full timeAs a Regulatory CMC Expert, this role is responsible for assisting RA CMC Director to develop and communicate CMC regulatory strategy based on understanding of local CMC regulations, involved in CMC regulatory project, providing the support and coordination on CMC dossiers preparation, submission and response; providing technical support and tactical...
-
Senior Director, Sourcing
4 months ago
Minhang District, China Centric Brands Full timeAbout Us Centric Brands is a leading lifestyle brand collective that designs, sources, markets and sells high quality products in multiple segments, including women’s, men’s and kid’s apparel, accessories, entertainment and beauty. Centric Brands is focused on our customers and our brands that will drive the company’s future growth. We are...
-
(Associate) Manager, Regulatory Affairs
5 months ago
Daxing District, China AstraZeneca Full timeDescription RA Manager , as an individual contributor, is responsible for developing regulatory strategy for the responsible projects with the guidance of senior regulatory manager; responsible for the regulatory strategy implementation by CTA/NDA submission/approval; responsible for HA interaction for regulatory strategy assessment with the guidance...
-
Global Sourcing Director
2 weeks ago
Minhang District, China Centric Brands Full timeAbout UsCentric Brands is a leading lifestyle brand collective that designs, sources, markets, and sells high-quality products in multiple segments, including women's, men's, and kid's apparel, accessories, entertainment, and beauty. Our company is focused on our customers and our brands that will drive the company's future growth. We are defined by...
-
Jinshan District, China Huntsman Full timeJob DescriptionThe successful candidate will play a key role in driving operational excellence across the Asia Pacific region, focusing on process improvement, quality management, and capital investment strategy. This is an exciting opportunity to join Huntsman's team and contribute to the company's growth and success.About the RoleThis role involves leading...
-
Senior Manager, Operations Excellence
5 months ago
Jinshan District, China Huntsman Full timeDescription : 1. Job Purpose Drive the successful delivery of Lean Six Sigma continuous improvement projects involving multiple departments and countries, suppliers and customers. Projects will create value by reducing cost, improve effectiveness, compliance, customer service, quality. The objective is to engage with the business units in...
-
Senior Manager, Operations Excellence
2 weeks ago
Jinshan District, China Huntsman Full timeJob SummaryWe are seeking a highly skilled and experienced Regional Operations Excellence and Quality Assurance Director to join our team at Huntsman. In this role, you will be responsible for driving continuous improvement initiatives across multiple departments and countries, with a focus on Lean Six Sigma principles and quality assurance.Key...
-
Senior Manager, Operations Excellence
4 weeks ago
Jinshan District, China Huntsman Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Operations Excellence to join our team at Huntsman. This is a unique opportunity to lead our operations excellence initiatives in the Asia Pacific region, driving continuous improvement and process excellence across our manufacturing sites.Key ResponsibilitiesLead the development and implementation...
-
Finance BP, China
1 month ago
Changning District, China Maquet (Shanghai) Medical Equipment Co., Full timeWith a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. ...
-
Senior Purchaser Electronic Components
2 weeks ago
Yangpu District, China Continental Full timeJob Title: Senior Purchaser Electronic ComponentsWe are seeking a Senior Purchaser Electronic Components to join our Electronics Purchasing Category Management team at Continental. This role offers a unique opportunity to drive and shape current developments in the car industry, focusing on electronic components.About the RoleAs a Senior Purchaser Electronic...
-
Physician Director
6 months ago
Daxing District, China AstraZeneca Full timeResponsible for products’ clinical development strategy and plan in multiple disease areas in R&D China. Responsible for managing reginal or China therapeutic or research projects or acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials. Will provide some input to medical science...
-
Tenant Coordinator
4 weeks ago
Changning, China Ikea Full timeJob SummaryAs a Tenant Coordinator at IKEA, you will play a crucial role in ensuring the smooth operation of our physical locations. Your primary responsibility will be to coordinate with various departments to guarantee that tenants have a seamless experience from move-in to move-out. This includes managing tenant design and decoration, coordinating with...
-
Electronics Category Manager
2 weeks ago
Yangpu District, China Continental Full timeCategory Management - ElectronicsAs a key member of our Electronics Purchasing Category Management team, you will play a pivotal role in driving and shaping current developments in the automotive industry.With increasingly higher portions of electronic components in modern cars, big platforms, and higher technical complexity, our team is tasked with finding...
-
(Sr.) Clinical Research Manager
6 months ago
Daxing District, China AstraZeneca Full timeRequires in depth knowledge and experience of a specialist field and will be recognised expert. Works independently requiring only minimal guidance. Solves complex problems and takes a new perspective using existing solution. May act as a coach or team leader for technicians or lower level scientists. Major Responsibilities Leadership of group work and...
-
Sr./Associate Director, CPM
6 months ago
Daxing District, China AstraZeneca Full timeBe responsible for the on time, quality, within budget delivery of global and local medical affairs clinical study and program for key products Prepare and deliver study level feasibility, and develop recruitment strategies , and the delivery of the approved Clinical Study Protocol .The job holder will lead a team to develop and deliver study results and...
-
Electronic Purchasing Buyer-DIS
4 weeks ago
Yangpu District, China Continental Full timeJob Description Join our Electronics Purchasing Category Management team as we are currently looking for experienced purchasers/buyers (m/f/d) Within this role you will drive and shape current developments in the car industry: Increasingly higher portion of electronic components in modern cars, big platforms and higher technical complexity are...
-
Logistics Specialist
2 weeks ago
Changning Qu, China Kuehne+Nagel Full timeOperational Care Team MemberYou will be a key player in the delivery of Operational Excellence by adding your expertise and skills to our team.Your RoleYou will enable transport activities by executing bookings, entering orders, and generating all required export documentation while liaising with our Customer Care Specialists to ensure all requirements are...
