งาน 3 ตำแหน่ง: งาน หางาน งานระเบียบและการอนุมัติผลิตภัณฑ์ทางการแพทย์
Senior Regulatory Affairs Specialistรหัส:75784
50,000 THB ~ 80,000 THBBTS (Silom Line)รายละเอียด
• Investigating whether the Health Product is a medical device requiring registration with MOH, determining its risk classification and route of submission.• Preparing and submitting applications for initial registration, renewals, and change notifications of medical device submissions, including follow-up until approval.• Promptly inform the manufacturer if there is any feedback from the Authority to ensure successful product registration.• Communicate with customers in response to their regulatory concerns.• Maintain the company's regulatory database.• Prepare regulatory intelligence reports by conducting research on relevant regulatory topics.• Monitor emerging regulatory trends to determine potential impact on internal projects, and draft regulatory updates for the Marketing Manager.• Assist the sales team in discussions with clients on regulatory matters, when required.• Develop and maintain standard operating procedures, local working practices, and regulatory affairs policies to ensure regulatory compliance is maintained or enhanced.• Liaise with external parties on matters relating to medical device regulatory requirements.• Report post-marketing activities to the Authority, such as mandatory problem reports, field safety corrective actions, recalls, and other required notifications.• Ensure awareness of obligations to comply with regulatory and other applicable statutory requirements, and of relevant top-management decisions, throughout the establishment and supply chain.
สวัสดิการ
- All compulsory public holidays in accordance with government regulations.
- Private health insurance (effective upon confirmation).
- Dental and optical claims (effective upon confirmation).
- Team-building activities.
- Paid training opportunities (effective upon confirmation).
- Annual performance bonus (eligible after 12 months of service, subject to company policy).
- Annual salary review (eligible after 12 months of service, subject to company policy).
- 13th-month salary (eligible after one full month of service, subject to company policy).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
50,000 THB ~ 60,000 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
