งาน 2 ตำแหน่ง: งาน หางาน งานระเบียบและการอนุมัติผลิตภัณฑ์ทางการแพทย์
Regulatory Affairs Officerรหัส:75659
50,000 THB ~ 70,000 THBBangnaรายละเอียด
1. Regulatory Intelligence- Monitor laws, regulations, announcements, and policies related to ammonia refrigeration systems, industrial safety, energy, environment, and labor- Prepare Regulatory Radar (monthly), Horizon Scan (quarterly), and Impact Briefs for management2. Impact Analysis- Analyze the impact of new regulations on design, installation, and maintenance processes- Identify required updates to specifications (Spec) and standard operating procedures (SOP)- Track regulatory and policy changes affecting customers (both positive, e.g., incentives, and negative, e.g., additional investment requirements)3. Internal Advisory- Provide early alerts to Engineering, Project, and Service teams regarding upcoming regulatory changes- Recommend updates to internal checklists prior to enforcement of new regulations- Advise Sales and Project teams on TOR (Terms of Reference) and contract documentation related to legal requirements4. Government & Stakeholder Liaison- Coordinate with government agencies such as DIW, TISI, DEDE, and BOI- Obtain technical clarifications and monitor policy direction- Prepare position papers on draft regulations, ensuring accuracy and transparency5. Opportunity Intelligence- Identify business opportunities arising from BOI policies and energy regulations- Highlight sales opportunities such as energy efficiency improvements- Develop playbooks for Sales teams to incorporate into customer proposals6. Promotion & Presentation- Present company capabilities, technologies, and strategies to government agencies and institutions- Share regulatory knowledge and industry trends with customers and private sector stakeholders- Represent the organization in seminars, conferences, and academic events
สวัสดิการ
Fixed Bonus 1 month and Incentive
Incentive
Social Insurance
Group Insurance
Meal Allowance
Provident fund 2%
Provide company car
OtherRegulatory Affairs and Quality Specialistรหัส:75651
60,000 THB ~ 80,000 THBMRT Line, Pathum Wanรายละเอียด
Key Responsibilities1. Regulatory Affairs- Ensure compliance with Thai FDA, MOPH, ASEAN Cosmetic Directive, and TISI (if applicable).- Handle product registrations, notifications, and license renewals.- Review formulations, labeling, and claims for regulatory compliance.- Track and implement regulatory updates in Thailand and SEA.2. Quality Assurance - Maintain and improve Quality Management Systems (QMS).- Ensure compliance with GMP and relevant ISO standards.- Approve raw materials, packaging, finished products, and vendor documents.- Conduct internal and supplier audits; support external audits.Manage deviations, complaints, and CAPA processes.3. Supplier & Manufacturing Oversight- Qualify and manage third-party manufacturers and suppliers.- Ensure manufacturing meets quality and regulatory requirements.- Support product scale-up and commercialization activities.4. Documentation & Reporting- Maintain SOPs, specifications, COAs, and regulatory records.- Prepare reports for internal teams and regulatory authorities.- Support inspections and audits by Thai FDA and other bodies.
สวัสดิการ
- SSO
- Guaranteed Bonus
- Health and life insurance
- Dental treatment benefits (5,000 THB per year)
- Provident fund contribution: 5%
- Annual leave: 8–14 days
- Other benefits
