Regulatory Affairs Specialist

3 weeks ago


Hanoi, Vietnam Công Ty TNHH Persolkelly Việt Nam Full time

**Mô tả công việc**:
(Mức lương: Thỏa thuận)
1. Regulatory affairs (approximately 10% of time commitment)
- Update the local regulation for the company.
- Establish working relationships with the internal and external parties (Local Health Services, external fellow RA professionals, market consultants, unofficial industry committees, official industrial bodies, Sales Channel Partners, RA consultants, contractors)
- Be responsible to follow up in matters associated with product recalls, product advisory notices, incident investigations or reporting.

2. Product registration (approximately 80% of time commitment)
- Monitor the requirements to register the licenses for the products as requirement of local regulation.
- Manage the plans for ensuring timely registration of new/updated product licenses
- Collaborate with global organizations and Regional Quality & Regulatory Manager(s) to collect all required documents for local product registrations.
- Prepare the registration dossiers.
- Register the Reimbursement healthcare code for medical consumables.
- Collaborate internal team/external authorities to disclore price for Medical Devices on the portal
- Collaborate internal team to manage Vietnamese label for importation goods.

3. Quality System (approximately 10% of time commitment)
- Support to implement tasks of QRA department as Integrated Management System (IMS), auditing (internal / external), management review, field action (TSB), medical device / non-medical device complaints, corrective and preventive actions program, hazard identification and risk assessment system, incident and accident registers.
- Support to monitor the implement of IMS of internal departments

**Chức vụ**: Nhân Viên/Chuyên Viên

**Hình thức làm việc**: Toàn thời gian

**Quyền lợi được hưởng**:

- Laptop
- Chế độ bảo hiểm
- Du Lịch
- Phụ cấp
- Du lịch nước ngoài
- Chế độ thưởng
- Chăm sóc sức khỏe
- Đào tạo
- Tăng lương
- Công tác phí
- Phụ cấp thâm niên
- Nghỉ phép năm

**Yêu cầu bằng cấp (tối thiểu)**: Trung cấp - Nghề

**Yêu cầu công việc**:
1. Education
- University degree or comparable business experience

2. Related Experience
- Minimum 3 years of working experience
- Experience with Regulatory Affairs

3. Skills, Special Competencies, or Certifications
- Strong knowledge of local regulatory framework
- Knowledge of quality management system
- Communication skills
- English: speaking, lisening, writing

**Yêu cầu giới tính**: Nam/Nữ

**Ngành nghề**: Dược Phẩm,Nghiên Cứu Và Phát Triển (R&D)

Trung cấp - Nghề
Không yêu cầu



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