Our Client:

Our client is a Japanese Regional HQ that focuses on medical technology for infection control and laboratory uses. Their office in Singapore also manages the sales and marketing for the Asia-Pacific region. With their high-quality standards, they are well-known in the Medical Industry. Currently, they are looking for a QA / RA Specialist to join their ever-growing team.

The Responsibilities:

Quality Assurance (QA)

* In-charge of QA (complaint reporting, etc.) for the entire region
* Analyze and make recommendations regarding complaints received and whether they are reportable within the designated areas; participate in post-market surveillance activities as necessary
* Submit complaint reports to factory, and follow up with investigation (with factory, subsidiary and/or customer)
* Report Field Safety Correction Action (FSCA) and adverse events to Authorities if needed
* Coordinate recall activities if needed
* Maintain database of all complaints and generating summary reports as and when necessary

Quality Management System (QMS)

* Act as Management Representative
* In charge of Good Distribution Practice for Medical Devices (GDPMDS) for Singapore office
* Conduct, take part, and support internal and external audits as required

Logistics

* Help to maintain the storeroom by keeping track of store going in and out
* Help in stocktake as and when needed

NEA Mandatory Packaging Reporting (MPR)

* In charge of National Environmental Agency (NEA) Mandatory Packaging Reporting (MPR)
* Helps in MPR submission to NEA
* Helps to compute the weight of packaging of goods sold in Singapore

Regulatory affairs

* 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 efficiently
* Provides advice to internal and external teams in interpreting relevant guidance documents and standards
* Contact with local authorities and organizations for both regulatory problems solving and obtain update 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 as necessary and assist with the development of the respective countries' Regulatory Affairs infrastructure to facilitate greater speed to market
* Generate regular reports to update on the status of registration

Others

* Any other reasonable duties as and when required

The Requirements:

* Minimum Diploma/Degree in relevant field with 1-2 years' experience in medical device regulatory affairs
* Deep interest in medical device regulatory affairs and quality assurance
* 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.