Executive - Quality Assurance (Regulatory Affairs)

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 issues 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 products 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 license, product listing and registration/certification.
• Ensuring all licenses and certifications are up to date (e.g., Canada Medical Device License, PPER Annual Assessment, FDA Annual Establishment, NFPA Annual Evaluation, etc.).
• Liaising with regulatory authorities and designated agents.
• Keep up to date with changes in regulatory legislation and guidelines.
• Review and update on adverse events, import alerts to management, and analyze the events reported.
• Keep alert with the new products and ensure necessary testing is conducted.
• Assure ongoing compliance by reviewing company practices and providing advice on changes to systems, such as Technical File, ISO documentation, and other regulatory issues.
• To review and update Technical File, PMS, PMCF, Clinical Evaluation, and all related regulatory documentation when necessary.
• Review sterile 510(k) listings and update to contract sterilizer accordingly.
• Undertaking and managing regulatory inspections (e.g., UL inspection).

Operation

• To provide support in attending customer inquiries related to regulatory and statutory requirements.
• Review labeling requirements (new or revise artwork) in accordance with regulatory requirements.
• To manage and facilitate product specifications.
• To manage and facilitate updating information in regulatory authority systems.
• To coordinate the review of Quality Agreement/External Product Specification with related stakeholders.
• To coordinate data compilation for New Introduction (NI)/New Product Development (NPD).
• Review and update 510(k) listings to all related parties.

REQUIREMENTS

• Bachelor’s Degree in Science or Engineering or any equivalent.
• Minimum of 2 years of working experience in a manufacturing environment or fresh graduates.
• Medical device regulatory knowledge will be an added advantage.
• Applicant must be willing to work at Sepang, Selangor.