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Ipoh

    Regulatory affairs manager - Ipoh, Malaysia - Factory & Marketing Office Kl-kepong Rubber Products Sdn Bhd

    Factory & Marketing Office Kl-kepong Rubber Products Sdn Bhd
    Factory & Marketing Office Kl-kepong Rubber Products Sdn Bhd Ipoh, Malaysia

    1 week ago

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    Full time
    Description

    Responsibilities:
    To manage medical device registration, 510(k) listing, medical device licensing and permit. To manage product testing and certification in compliance with regulatory requirements. To liaise with medical device authorities, representatives, and certification bodies. To provide technical support to Sales team on regulatory enquiries and product compliances. To provide regulatory guidance to R&D team on product design, testing and validation. To collaborate with QA team to ensure product meeting regulatory standards for safety, efficacy, and quality. To handle audits for regulatory compliances. To maintain medical device file and documentation. Responsible for overall regulatory compliances of products throughout the product life cycle.


    Requirements:
    Possess a minimum Degree in Chemistry or Engineering. Experience in regulatory affairs from medical glove industry a must. Proficient in English, both written and verbal. Demonstrate initiative, drive, and resilience, resourceful and has the ability to work independently as well as in a team.
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