
QA/ra Manager Jo-230321-308635
12 hours ago
**Location**: Singapore
**Salary**: Open
**Industry**: Healthcare & Life Sciences
**Sub-industry**: Medical Devices
**Function**: Healthcare R&D
**Job Description**:
**Our Client**:
Our client is a Japanese Regional HQ that focuses on medical technology for infection control and laboratory uses. They manage the sales and marketing for the Asia-Pacific region and with their high-quality standards, they are well-known in the medical industry. Currently, they are actively looking for a QA/RA Manager to join their team in Singapore.
**The Responsibilities**:
- Oversee QA department in handling complaint reporting, etc.
- Analyze and propose recommendations regarding complaints received and whether they are reportable within the designated areas; participate in post-market surveillance activities when necessary
- Report Field Safety Correction Action (FSCA) and adverse events to Authorities if needed
- Coordinates the process of product registration and market access approval in the designated countries including providing all required documents and certificates within the specified timeframe proactively to complete product registration
- Provides advice to internal and external teams in interpreting relevant guidance documents and standards
- Contact local authorities and organizations for both regulatory problems solving and obtain updated information on current and developing regulations
- Review and approve documents to support Post Market Change notification (including labelling changes) to reach compliance with international regulations and standards
- Remain up to date on regulations and communicate any key changes to stakeholders in the broader organization
- Provide training and assist the development of the respective countries' Regulatory Affairs infrastructure to facilitate greater speed to market
- Assist to support tenders for all subsidiaries with regulatory certs and technical documents as and when needed
- Keep track of all product changes and artwork changes
- Any other ad hoc duties which the superior may assign from time-to-time
**The Requirements**:
- Minimum Degree in relevant studies
- Minimum 5 years' experience in Regulatory Affairs / Quality Assurance role in the Medical Devices industry
- Possess managerial experience leading / managing a team
- Ability to handle regional subsidiaries over 8 countries
- Great interpersonal & communication skills
- Able to work independently and a team player
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