Key Responsibilities will include

• Responsible for supporting the implementation of Vision RT’s Quality Management System at its manufacturing, sales, service and distribution sites in China and South Korea.
• Liaise with Vision RT’s local sales, importation, distribution and service partners to ensure high standards of quality are met for Vision RT’s products and documentation for importation, inspection, distribution and returns.
• Perform quality inspections of imported products and product returns.
• Create and maintain formal records required to support regulatory compliance for Vision RT’s operations and products in South Korea.
• Support the Quality, Regulatory and Compliance team located in the UK with liaising with the KFDA and local partners and understanding regulatory requirements in South Korea.
• Submit post-market reports as required.
• Support the Quality Manager at Vision RT Beijing with reviewing and filing quality records.
• Plan, lead and document audits of Vision RT’s suppliers and internal functions in the A{AC area.
• Other duties as reasonably required.
• This role requires local and international travel.

Essential Skills & Experience

• Previous experience in medical device regulatory affairs, quality assurance and/or quality control.
• Knowledge of ISO 13485:2016 and the Korean Good Distribution Practice.
• Fluent written and spoken Korean.
• At least C1-level written and spoken English.
• Excellent report-writing and presentation skills.
• Must be able to render clear and accurate judgements.
• Ability to use Microsoft Word, Excel and Outlook.

Must have one or more of the following qualifications:

• A person who holds a radiological technologist license under the Medical Service Technologists, etc. Act of Korea (if radiation-generating devices are manufactured or imported);
• A person with qualifications as a biomedical engineer or quality management engineer under the National Technical Qualifications Act of Korea, or a person with qualifications as a regulatory affairs expert as approved by the Minister of Food and Drug Safety of Korea under Article 19, Paragraph 1 of the Framework Act of Qualifications of Korea;
• A person who has obtained a bachelor’s degree in a university, college, etc. (including a person deemed under relevant laws to have equal or higher educational degree and excluding a community college) in the field of natural science, engineering, or medicine (hereinafter “Medical Devices-Related Field”);
• A person who has obtained a bachelor's degree from a university, college, etc. (excluding a community college) in a field not related to medical devices but obtained a master's degree or higher from a graduate school in the Medical Devices-Related Field;
• A person who has obtained a bachelor's degree from a university, college, etc. (excluding a community college) in a field not related to medical devices and has worked in quality control for at least one year (including the period of service before the person was graduated or otherwise was deemed to have obtained the degree) in a company that manufactures or imports medical devices;
• A graduate of a community college (including a person deemed under relevant laws to have equal or higher educational degree) who has majored in the Medical Devices-Related Field and worked in quality control for at least one year in a company that manufactures or imports medical devices;
• A graduate of a community college who has majored in a field not related to medical devices but worked in quality control for at least three years (including the years of service before the person was graduated or otherwise was deemed to have obtained the degree) in a company that manufactures or imports medical devices;
• A graduate of a high school or trade school (a high school equivalent) (including a person deemed under relevant laws to have equal or higher educational degree) who has worked in quality control for at least five years in a company that manufactures or imports medical devices;
• A graduate of a high school specializing in meeting industry demand in the Medical Devices-Related Fieldwho has worked in quality control for at least three years in a company that manufactures or imports medical devices; or
• A person who has worked in quality control for at least six years in a company that manufactures or imports medical devices.