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Regulatory Affairs Specialist

4 months ago

Hanoi, Vietnam PERSOLKELLY Vietnam Full time

**Purpose of Function**
- Regulatory affairs and product registration for product license for medical devices and non-medical devices accordance to local laws.**Tasks and Responsibilities**

**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.

**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 portal
- Collaborate internal team to manage Vietnamese label for importation goods.
- **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

**Position Requirements**
- Education- University degree or comparable business experience- Related Experience- Minimum 3 years of working experience
- Experience with Regulatory Affairs- Skills, Special Competencies, or Certifications- Strong knowledge of local regulatory framework
- Knowledge of quality management system- Communication skills
- English: speaking, lisening, writing569438