EXECUTIVE / ENGINEER - QUALITY ASSURANCE, REGULATORY AFFAIRS

Company Overview

Leading Growth Through Innovation

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.

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

Additional Company Information

Registration No. Company Size

75398-K More than 5000 Employees

Average Processing Time Industry

21 days Manufacturing / Production Regulatory, Iso Documentation, Sops, Product Development