Director Quality and Regulatory Compliance, Eastern Asia

3 weeks ago

Changning District, China Maquet (Shanghai) Medical Equipment Co., Full time

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.

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