Executive - Regulatory Affairs

2-5 years
7 months ago 12 Applied
Job Description

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

  • 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.

  • To assist Manager to ensure the appropriate licensing and legal compliance of products in order to control the safety and efficacy of products.

  • To assist Manager to manage and facilitate all submissions e.g. 510(k) and/or renewal of licence, product listing and registration / certification.

  • Liaising with regulatory authorities and designated agents.

  • Provide ongoing support to product development for regulatory issues and questions.

  • Provide regulatory support to currently marketed products as necessary.

  • Keep up to date with changes in regulatory legislation, guidelines and etc.

  • 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.

  • To update Technical File and all related regulatory documentations when necessary.

  • Review labelling, storage and packaging requirements in accordance to Packaging Material Labelling Requirement Checklist.

  • 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.

  • Provide training, guidance and coaching to subordinates (if any).


  • Minimum Bachelor's Degree in Science (Chemistry)or any equivalent.

  • Minimum 2 years of working experience in manufacturing environment.

  • Excellent in communication(written &spoken)



Executive - Regulatory Affairs
Job Source: wd3.myworkdaysite.com

As the World's No.1 Nitrile Glove manufacturer, Hartalega is currently in the process of recruiting a diverse pool of talented people, across various specialisations and backgrounds. You will enjoy exceptional benefits and incentives, as well as a well-defined path for career success. Hartalega is made up of a tight-knit, passionate and highly-skilled set of individuals. From our top executives, to our line technicians we are all proud to be part of an elite group responsible for revolutionising the glove-making industry.

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