Quality Assurance, Regulatory Affairs Engineer null

About Hartalega

Operating since 1988, Hartalega is known as the World's No.1 Nitrile Glove manufacturer. The Company offers latex and nitrile gloves for manufacturing, healthcare, and laboratory sectors.

Your role

Overview

• The incumbent is responsible to maintain and ensure that the company and product manufactured to comply with regulatory and statutory requirements as well as providing support for issues related to regulatory and statutory requirements.

Duties & 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 licenses, product listing, and registration/ certification.
  • Ensuring all licenses and certifications 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 the adverse events, import alerts to management and analyze the event reported.
  • Keep alert with the new product and ensure necessary testing is conducted
  • Assure ongoing compliance by reviewing company practices and providing advice on changes to the system, such as Technical Files, 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) listing and update to contract sterilizer accordingly
  • Undertaking and managing regulatory inspections (eg: 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 specification
  • To manage and facilitate updating information in the regulatory authority system
  • To coordinate review of Quality Agreement/ External Product Specification with related stakeholder
  • Coordinate data compilation for New Introduction (NI)/ New Product Development (NPD)
  • Review and update 510(k) listing to all related parties.

Training & development 

Referring to its official website, Hartalega provides detailed learning & development statistics they provide for all of its employees. They are investing in the future with:

• 600+ training programs linked to competency
• 380+ structured on-the-job-training modules
• 600+ competencies mapped
• 280,000+ total training hours

Compensation & benefits

Based on what we gain from another source, the role of QA Engineer at Hartalega will make you receive an annual salary that ranges from MYR 38,000 to MYR 66,000. (source:glassdoor.com)

Career progression

Working at Hartalega will allow you to have a lot of options in career development. Below are the career development programs that Hartalega offers to its people:

• Human Resources Transformation Programme
• Induction Programme
• Competency Development Programme
• Leadership Competency Programme
• Hartalearns^TM
• Educational & Financial Assistance

Work-life balance

Hartalega applies standard working hours from 9 AM to 6 PM, Monday to Friday. However, if you are placed at the factory, you may need to work on a rotating shift. Related to the working hours, most employees who reviewed online stated they did not have any issues with work-life balance when they worked at Hartalega.

Company culture

The company instills its fundamental principles in all of its Hartanians, motivating them to uphold these principles and contribute to the global aim of enhancing lives. Above all, it serves as the foundational premise for how each Hartanian interacts with coworkers, vendors, clients, and other collaborators.

About you

To apply for this role you are required to have the following 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.

How to apply

To apply for this position, click the button "Apply on employer site" on this page. We will direct you to Hartalega's official link for this vacancy. Please be sure that you have read all of the requirements mentioned above.