Quality Assurance Executive

Responsibilities

• To manage the regulatory compliance function of the company, which include medical device registration, post market surveillance, clinical evaluation.
• To ensure compliance with regulatory requirements from countries / regions such as the EU (MDR), US (FDA), Malaysia (MDA) and so on.
• To develop and maintain Technical Documentation for each medical device category.
• To participate in developing and maintaining Standard Operating Procedures, Work Instructions and Specifications that comply with the relevant regulatory and customer requirements.
• To keep abreast of the regulatory changes and its implications, keeping management apprised at all times.

Profile :

About Us

Established in 1989, Elastomade Accessories Sdn. Bhd. began with dental dam manufacturing and expanded into sheeting, exercise bands, loop bands, and latex garments. As market demands evolved, we transitioned into latex-free solutions and now offer advanced TPE formulations with performance comparable to natural latex.

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