Executive - Regulatory Affairs

OVERVIEW
The incumbent is responsible to assist Manager to maintain and ensure that product manufactured, and company comply with regulatory and statutory requirements.
DUTIES & RESPONSIBILITIES

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  To ensure products manufactured or distributed comply with the required regulations, such as Food & Drug Administration (FDA), Medicines and Healthcare Products Regulatory Agency (MHRA), Canadian Medical Device Regulation (CMDR) and etc.
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  To assist Manager to ensure the appropriate licensing and legal compliance of products in order to control the safety and efficacy of products.
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  To assist Manager to manage and facilitate all submissions e.g. 510(k) and/or renewal of licence, product listing and registration / certification.
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  Liaising with regulatory authorities and designated agents.
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  Provide ongoing support to product development for regulatory issues and questions.
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  Provide regulatory support to currently marketed products as necessary.
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  Keep up to date with changes in regulatory legislation, guidelines and etc.
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  Assures the ongoing compliance by reviewing company practices and provide advice on changes to systems, such as Technical File, Risk Management File, ISO documentation and other regulatory issues.
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  To update Technical File and all related regulatory documentations when necessary.
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  Review labelling, storage and packaging requirements in accordance to Packaging Material Labelling Requirement Checklist.
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  Conduct Internal Quality Audits as per HSB-SOP-036 Internal Audits covering all elements in the ISO 9001, ISO 13485, CMDR, Medical Device Directives (MDD 93/42/EEC), US FDA Quality System Regulation and Japanese Good Manufacturing Practices.
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  Provide training, guidance and coaching to subordinates (if any).

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  Minimum Bachelor's Degree in Science (Chemistry)or any equivalent.
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  Minimum 2 years of working experience in manufacturing environment.
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  Excellent in communication(written &spoken)