Regulatory Affairs Supervisor (RAS)
บริษัท เออร์โก้ เฮลธ์แคร์ โพรดัคส์ จำกัดSupervisor : QA& RA Manager
Subordinate : RA officer, RA Specialist
Responsibility and authority :
- Organize the Regulatory file / Technical documents for products under UHP legal manufacturer in compliance with EU MDR 2017/745.
- Manage of packaging artworks validation (e.g. primary packaging, secondary packaging, leaflet) for products under UHP legal manufacturer in compliance with EU MDR 2017/745.
- Organize the Post Market Surveillance (PMS) report.
- Manage of Product Registration in EUDAMED system for products which marketed in European Union (EU).
- Lead and organize the patient/user risk analysis file creation.
- Report of Device Defect/Adverse Event and FSCA to EU health authorities/EUDAMED system.
- Acts as the Person Responsible for Regulatory Compliance (PRRC) of the UHP factory (legal manufacturer) in compliance the EU MDR 2017/745.
- Review and approve of product information and UDI-DI/GTIN for GS1 Thailand registration.
- Create and manage the Basic-UDI for CE marked products under UHP legal manufacturer.
- Organize the translation of packaging artwork of products under UHP legal manufacturer.
- Organize and control of regulatory file, documents and record.
- Ensure the communication with Economic operators/stakeholders is made for any changes affecting products under UHP legal manufacturer.
- Review the dossiers of Common submission dossier template (CSDT) for Regulatory submission in compliance with ASEAN Medical Device Directive (AMDD).
- Manage of product registration, variation submission and license renewal for Thai FDA submission.
- Review the Product Specification Sheet for products under UHP legal manufacturer requested by customers.
- Manage the validation of Thai translation of packaging artworks (e.g. primary packaging, secondary packaging, leaflet) for products under LU/LUH/UM legal manufacturer.
- Review the dossiers for the submission of Manufacturer’s Certificate to Export listed/notified/licensed medical devices (ผอ. 1) and the submission of Certificate of Free Sale (CFS), Certificate for Exportation (CE), certificate of Manufacturer (CM) or Certificate of Origin (CO) upon customer’s requests.
- Review and approve of documents for annual report submission.
- Review the dossiers for variation submission for the establishment licenses both importer (สน.) and manufacturer (สผ.).
- Review the report of Device Defect/Adverse Event and FSCA for Thai FDA submission.
- Keep abreast of new and revised regulations affecting UHP’s products and ensure that the communication between UHP RA and Regional RA/local RA/ Global RA is made.
- Cooperate with RA’s legal manufacturer or regional RA for any adverse event to report Thai regulatory authorities.
- Collaborate and supporting to regulatory team for products (under UHP legal manufacturer) registration in each country.
- Supporting to RA team to register products (under UM or LUH legal manufacturer) in Thailand.
- Organizing the legalization or notarization of the ISO certified true copy or documents upon customer’s requests.
- Organizing and supporting during audit by FDA.
- Participate during meeting or seminar which organized by Thai FDA.
- Organize Procedure, Work instruction and Form related to RA process.
- Ensure compliance with regulations and company’s policies/SOP/guidance.
- Support analysis/ activities/ communications from RA perspective of product complaints, adverse events and file action, etc.
- Preparing monthly the quality KPI’s report to QA Manager.
- Organizing training for subordinate.
- Support and cooperate on the Environmental Management Systems establishment.
- Other responsibilities that assigned by direct manager.
- Computer skills (MS Words, Excel, Power point, Internet and others).
- Good command of English (Reading, writing and speaking).
- Good communication for listening, speaking, writing and negotiation skill.
- Understanding requirement of AMDD, ISO standard, GMP , CE mark or other standard / regulation for medical device and can provide or prepare the related document.
- Understanding of Quality Assurance process, Quality control and Quality management system.
- Good problem-solving skills and interpersonal skills.
- Understanding process to contact FDA.
- กองทุนสำรองเลี้ยงชีพ
- การฝึกอบรมและพัฒนาพนักงาน
- ค่าน้ำมันรถ, ค่าเดินทาง
- ค่ายินดีมงคลสมรส
- ค่าอนุโมทนาอุปสมบท
- ทำงานสัปดาห์ละ 5 วัน
- ประกันสังคม
- ประกันสุขภาพ
- ประกันอุบัติเหตุ
- มีเวลาการทำงานที่ยืดหยุ่น
- ลาบวช
- เครื่องแบบพนักงาน, ชุดยูนิฟอร์ม
- เงินช่วยเหลือฌาปนกิจ
- เที่ยวประจำปี หรือเลี้ยงประจำปี
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