Director Quality and Regulatory Compliance, Eastern Asia

Date: Aug 30, 2024

Location:Shanghai, Changning District, CN

Company: Maquet (Shanghai) Medical Equipment Co.,

Remote Work:

• 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.

• 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.

• 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.

• 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.