EXECUTIVE / ENGINEER - QUALITY ASSURANCE, REGULATORY AFFAIRS

Job Description

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 necessary
• Conduct training related to regulatory (Internal and SOJT Training)
• Conduct Mock Recall
• Any other tasks assigned by the superior.

 Project

• To ensure products manufactured or distributed comply with the required regulations
• To 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 conducted
• Assure 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 accordingly
• Undertaking and managing regulatory inspections (eg: UL inspection)

Operation

• To provide support in attending customer enquires related to regulatory and statutory requirements
• Review labelling requirements (new or revise artwork) in accordance with regulatory requirement.
• To manage and facilitate product specification
• To manage and facilitate in updating information in regulatory authority system
• To coordinate review of Quality Agreement/ External Product Specification with related stakeholder
• To 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 advantage