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
Disclaimer: The Company complies with the Tripartite Guidelines on Fair Employment Practices (TGFEP), including the prevailing guidelines on recruitment. All qualified applicants will be considered for the position regardless of their age, race, religion, nationality, marital status, or family responsibilities. A more detailed discussion of the TGFEP is available on the Tripartite Alliance for Fair and Progressive Employment Practices (TAFEP) website at https://www.tal.sg/tafep.