Regulatory Affairs (RA) Executive

EPS Malaysia; Kuala Lumpur; On-site; MYR 30,000 - 50,000; Full time

Job summary

An established industry player is seeking a dedicated Regulatory Affairs Assistant to support their compliance efforts in the medical device sector. This role involves maintaining regulatory documents, preparing submissions, and participating in audits to ensure adherence to industry standards. If you are detail-oriented and passionate about regulatory processes, this is a fantastic opportunity to contribute to a company that values quality and safety in its products. Join a dynamic team and help shape the future of regulatory compliance in a growing industry.

Qualifications

• At least a Diploma or Degree in Engineering, Biology, Chemistry, or related field.
• Minimum 1 year of experience in a related field.

Responsibilities

• Assist in maintaining Regulatory Affairs and Medical Device registrations.
• Prepare documents for License and Regulatory Registration submissions.
• Participate in Internal Audits and Regulatory Audits.

Skills

Regulatory Affairs

Document Management

Regulatory Compliance

Team Collaboration

Education

Diploma in Engineering

Degree in Biology

Degree in Chemistry

Job description

Posting Date : 30 Apr 2025 | Close Date :29 Jul 2025

Client Background:

Our Client is a leading supplier with strong credentials in the latex dipped products industry, Male latex condoms,Personal Lubricant,Prophylactic Oral Dam,Transducer Probe Covers,Dental Dams, Resistance / Exercise Bands.

Headcount: 1

Remuneration: Basic + Benefits

Responsibilities:

1.Assisting in maintenance of the company’s Regulatory Affairs and applicable Jurisdiction Medical Device registration and registration maintenance.

2.Assisting in maintaining regulatory documents in good order.

3.Reviewing and updating external document master list, keeping up to date with changes in Regulatory Legislation and Guidelines

4.Gathering and updating Regulatory Registration Master List periodically to reflect up to date product status and regulatory information.

5.Preparing document for License and Regulatory Registration submissions and renewals on a timely manner.

6.Collecting and coordinating information and preparing regulatory documentations for submission to Regulatory Authorities or to commercial partners.

7.Collecting and coordinating information and preparing regulatory documentations for endorsement.

8.Contacting and arranging endorsement of regulatory certificates and licenses obtained from the authority

9.Assisting in identify incidents/ issues which requires advisory notice/ filed safety notice/ filed safety corrective action.

10.Assisting in reporting and vigilance activities.

11.Distributing User Feedback Questionnaires to customers and following up in a timely manner.

12.Distributing User Feedback Questionnaires to customers and following up in a timely manner.

13.Gathering and analyzing User Feedback data and preparing User Feedback Analysis report.

14.Assisting in the preparation for Regulatory Audit.

15.Participating in Internal Audits, Supplier/ OM’s period evaluation audit and External Audit.

16.Participating in Risk Management Team.

17.Performing other work related functions as assigned by superior

Requirements:

·At least Diploma/ Degree in Engineering / Biology/ Chemistry or any related.

·Min 1 year of working experience in related field.

·Must be able to work in Bandar Tasik Selatan area.

·Ability to work in team work and independently.

Sub Specialization : Others;Any

Type of Employment : Permanent

Minimum Experience : 1 Year

Work Location : Kuala Lumpur

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