OVERVIEW The incumbent is responsible to maintain and ensure that company and product manufactured comply to regulatory and statutory requirements as well as providing support for issue related to regulatory and statutory requirements.DUTIES AND RESPONSIBILITIES General Provide ongoing support to product development for regulatory issues.Provide regulatory support to currently marketed product as necessary.Review and revise related SOPs whenever necessaryConduct training related to regulatory (Internal and SOJT Training)Conduct Mock RecallAny other tasks assigned by the superior. Project To ensure products manufactured or distributed comply with the required regulationsTo ensure and maintain the appropriate licensing and legal compliance of products to control the safety and efficacy of products.To manage and facilitate all regulatory submissions and/or renewal of licence, product listing and registration/ certification.Ensuring all licence and certification are up to date (eg: Canada Medical Device License, PPER Annual Assessment, FDA Annual Establishment, NFPA Annual Evaluation and etc)Liaising with regulatory authorities and designated agents.Keep up to date with changes in regulatory legislation, guidelines and etc.Review and update on adverse event, import alert to management and analyse the event reported.Keep alert with the new product and ensure necessary testing is conductedAssure the ongoing compliance by reviewing company practices and provide advice on changes to system, such as Technical File, ISO documentation and other regulatory issues.To review and update Technical File, PMS, PMCF, Clinical Evaluation and all related regulatory documentations when necessary.Review sterile 510(k) listing and update to contract sterilizer accordinglyUndertaking and managing regulatory inspections (eg: UL inspection)Operation To provide support in attending customer enquires related to regulatory and statutory requirementsReview labelling requirements (new or revise artwork) in accordance with regulatory requirement.To manage and facilitate product specificationTo manage and facilitate in updating information in regulatory authority systemTo coordinate review of Quality Agreement/ External Product Specification with related stakeholderTo coordinate data compilation for New Introduction (NI)/ New Product Development (NPD)Review and update 510(k) listing to all related parties.REQUIREMENTS Bachelor's Degree in Science or Engineering or any equivalent.Minimum of 2 years of working experience in manufacturing environment or fresh graduates.Medical device regulatory knowledge will be an added advantageApplicant must be willing to work at Sepang, Selangor