QA/ra
1 week ago
**Role & Responsibility**:
- prepare, register, and gather documents related to registration process to get both new and renew import licenses e.g. Certificate of Free Sale/ Certificate of Goods/ Free Sale Certificate, ISO/ any other applicable standard certificate, product catalog/ brochure, Instruction for use/ Notice, and declaration letter(if needed).
- Support any Quality Regulatory Compliance related special projects that assigned by company policy as well as by the change of Thai FDA regulation and requirement.
- Incorporate with QA/RA manager to oversee the changes and/ or new legislations, requirements, applicable standard and/ or requirement that lead to impact to registration process and Quality Management System.
- Gather, file, and maintain all data/ information regarding FSCA/ AE/ Customer Complaint and any other related QA/RA issues.
- Act as Document Control Center to handling all quality and regulatory documents related to applicable standard for Quality Management System.
**Knowledge/Skills/Experience**:
- Bachelor’s Degree in Science, Medical or related fields.
- 2-3 years of experience in Medical Device products registration process or related field.
- Knowledge of registration process and/ or DCC for any applicable QMS is a must. (ISO13485)
- Good command in English & Thai both written and spoken.
- Good computer literacy (MS Office: Word, Excel, Access, and Power Point).
ประเภทของงาน: งานประจำ
-
Regulatory Authority, Ra/qa
1 week ago
หลักสี่, กรุงเทพมหานคร, Thailand Reeracoen Thailand Full time**Overview**: **Salary**: 30,000 THB ~ 50,000 THB**Industry**: Medical, Manufacturing(Chemicals/Materials)- Support any Quality Regulatory Compliance related special projects that assigned by company policy as well as by the change of Thai FDA regulation and requirement. - Prepare, register, and gather documents related to registration process to get both...
-
Ra/qa Manager
3 weeks ago
หลักสี่, กรุงเทพมหานคร, Thailand Reeracoen Thailand Full time**Overview**: **Salary**: 70,000 THB ~ 100,000 THB**Industry**: Medical, Manufacturing(Chemicals/Materials)- Responsible for Medical product registration, renewal, post approval changes and advertising approval by Thai FDA in compliance with Thai FDA regulations. - Prepare registration dossier according to FDA requirement and prepare the documents for post...
-
Ra & QA Manager
1 week ago
กรุงเทพมหานคร, Thailand Straumann Full timeMain Purpose of the Role **Responsibilities**: 1. Regulatory Affairs: Communicate and align with commercial and marketing lead, and other stakeholders on the registration plan and strategy, and timely update on the status as well as the actions taken to address any delay or potential delay. Coordinate, compile, submit and process regulatory submissions for...
-
Ra & QA Manager
1 week ago
กรุงเทพมหานคร, Thailand Straumann Full time**Main Purpose of the Role** **Responsibilities**: **1. Regulatory Affairs**: - Communicate and align with commercial and marketing lead, and other stakeholders on the registration plan and strategy, and timely update on the status as well as the actions taken to address any delay or potential delay. - Coordinate, compile, submit and process regulatory...
-
Ra/qa Manager
5 days ago
หลักสี่, กรุงเทพมหานคร, Thailand PRTR Full timeOur client is a leading medical device manufacturer in Thailand. **Key Responsibilities** - Interacting and coordinating with regulatory agencies to expedite the approval of registrations. - Assisting in reviewing regulatory documents and materials such as package inserts, labels, and other packages. - Supporting other regulatory issues such as COA...
-
Regulatory Affairs Assistant Manager
2 days ago
กรุงเทพมหานคร, Thailand Healthcare (OHQ) Full time**Job Title**:Regulatory Affairs Assistant Manager **Location**:Krung Thep Maha Nakhon Bangkok, Thailand**Employment Type**:Permanent**About OMRON** - Founded in 1933, OMRON has come a long way since and has evolved to become an organization committed to creating new social values. Today, In the APAC region, OMRON has a strong presence in Industrial...
-
Regulatory Affairs Assistant Manager
3 weeks ago
กรุงเทพมหานคร, Thailand Unilever Full timeCompany: Unilever Thailand Holdings Business Function: Research & Development Job Title: Regulatory Affairs Assistant Manager, Thailand - Home Care Scope: Local Work Location: Unilever House Employment Type: Full Time The Purpose of Role: Regulatory Affairs (RA) role in Thailand is responsible for ensuring regulatory compliance of innovation projects...
-
R&d Pharmacist
3 weeks ago
กรุงเทพมหานคร, Thailand Thai-Otsuka Co.,Ltd Full time**_Otsuka people creating new products_** **_for better health worldwide_**: is our philosophy that all Otsuka family globally know that they will be highly valued and encouraged to fulfill their potentials. We provide a welcoming, friendly and inspiring work environment that nurtures their growth and passion, as an individual and as part of a team, and...
-
Senior International Purchaser
5 days ago
ยานนาวา, กรุงเทพมหานคร, Thailand บริษัท คอสมิค คอนคอร์ด คอร์ปอเรชั่น จำกัด Full timeรายละเอียดงาน **รูปแบบงาน **:งานประจำ**จำนวนที่รับ **:1 ตำแหน่ง**สถานที่ปฏิบัติงาน...
-
Qms Quality Manager, Kcp Apac
4 days ago
กรุงเทพมหานคร, Thailand Kimberly-Clark Full time**Your Job**: This role will be responsible for quality and regulatory management practices/systems applicable to the KCP Business In your **QMS Quality Manager, KCP APAC **role, you’ll help us deliver better care for billions of people around the world. **About Us**: People have looked to Kimberly-Clark brands for more than 150 years and today we're...