FDA&TISI Regulatory Affairs Specialist/เจ้าหน้าที่ขึ้นทะเบียนผลิตภัณฑ์
บริษัท จอห์นสัน เฮลธ์ เทค (ประเทศไทย) จำกัด
- Bang Phli, Samut Prakan
- Permanent
- Full-time
- Responsible for product registration and variation, mainly in massages chairs, massages accessories and other related products that required to meet rules & regulations from all concerned Laws.
- Collaborate with JHT Group factories, JHT-IPO, especially Wellness team and other vendors or manufacturer to provide & support all neccessary documents and regulatory compliance activity as FDA, TISI, Customers and other related Government sector requirement
- Renewal all existing licenses with competent authorities to ensure the company can get the right and timely license.
- Verify and prepare necessary documents for the request product to comply regulatory requirements.
- Collaborate with Marketing, Sales department and other related departments for aministrative support in regulatory affairs activities.
- Maintain the tracking records and update database of regulatory affairs activities on weekly and monthly basis with a manner timeline.
- Mornitor and manage chaging/updating of requlatory activities related regulations, product registration and vairation according to reference guidelines.
- Keep monitoring KA customer complaints and coordinate with Sales, Call-Center, CS to follow up all complaints and take action within a timely manner.
- Make Daily pending case report for special customer(Jetts) to HQ and all concerned.
- Support for special project or assigned by Operations Director.
- Regulatory & compliance.
- Excellent leadership, time management and communication skills.
- Have positive thinking, patience, honesty, high ehics, work
- Effective ability to communicate orally or in written form effectively in English and Thai with co-management, internal and external.
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