JOB DETAILS

JOB DETAIL

To support and align the applicable QMS within the organization by acting as the Organization’s Document Control Center.
To oversee, drive, and maintain the registration process to get import licenses as required by organization strategy and policy.

(Job Descriptions)
• Support any Quality Regulatory compliance-related special projects that are assigned by company policy as well as by the change of Thai FDA regulation and requirements.
• Prepare, register, and gather documents related to the registration process to get both new and renewed import licenses e.g. Certificate of Free Sale, Certificate of Goods, ISO certificate, any other applicable standard certificate, product catalog/brochure, Instruction for use/Notice, and declaration letter (if needed).
• To oversee the changes and/or new legislations, requirements, applicable standards, and/or requirements that lead to an impact on the registration process and Quality Management System.
• Gather, file, and maintain all data/ information regarding FSCA/ AE/ Customer Complaints and any other related QA/RA issues.
• Act as a Document Control Center to handle all quality and regulatory documents related to applicable standards for the Quality Management System.

REQUIRED WORK EXPERIENCE

• Male or Female, Age 35 - 40 years old.
• Bachelor’s Degree in Science, Medical, or related fields.
• At least 3 years of experience in Regulatory Affairs, (ISO13485), registration process of medical device products, or related fields.
• Over 7 years of experience in Quality Assurance
• Have good experience in working with the FDA in the preparation of documents for product registration until product marketing approval.
• Understanding of the rules and regulations of medical products.
• Strong problem-solving and prioritization skills
• Knowledge of the registration process and/ or DCC for any applicable QMS (ISO13485).
• Good command of English & Thai both written and spoken.
• Good computer literacy (MS Office: Word, Excel, Access, and PowerPoint).
• Good coordinator, relationship, and communication skills with other departments.
• Good interpersonal skills and Service Orientation.
• Ability to do multi-tasks & manage priorities under pressure.