
Regulatory Affairs (RA) Executive (Manufacturing based in Kuala Lumpur)
RM 2,500 - RM 3,000 / month
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- Assisting in maintenance of the company's Regulatory Affairs and applicable Jurisdiction Medical Device registration and registration maintenance.
- Assisting in maintaining regulatory documents in good order.
- Reviewing and updating external document master list, keeping up to date with changes in Regulatory
- Legislation and Guidelines.
- Gathering and updating Regulatory Registration Master List periodically to reflect up to date product status and regulatory information.
- Preparing document for License and Regulatory Registration submissions and renewals on a timely
- manner.
- Collecting and coordinating information and preparing regulatory documentations for submission to
- Regulatory Authorities or to commercial partners.
- Collecting and coordinating information and preparing regulatory documentations for endorsement.
- Contacting and arranging endorsement of regulatory documents with the Regulatory Agency.
- Assisting in review the related product registration certificates and licenses obtained from the authority.
- Assisting in identify incidents/ issues which requires advisory notice / field safety notice/ field safety
- corrective action.
- Assisting in reporting and vigilance activities.
- Distributing User Feedback Questionnaires to customers and following up in a timely manner.
- Gathering and analyzing User Feedback data and preparing User Feedback Analysis Report.
- Assisting in the preparation for Regulatory Audit.
- Participating in Internal Audits, Supplier/ OM's periodic evaluation audit and External Audit.
- Participating in Risk Management Team.
- Performing other work related functions as assigned by superior.
Requirements
- Minimum a Diploma in any field.
- At least 2 years of RA experience from any industry.
- Candidate from manufacturing industry are added advantage.
- Good in English (Spoken & Written)
- Working hour: Mon-Fri (9am-5.30pm)
Job Types: Full-time, Permanent
Pay: RM2,500.00 - RM3,000.00 per month
Benefits:
- Health insurance
Schedule:
- Monday to Friday
Supplemental Pay:
- Performance bonus
Application Question(s):
- Are you willing to work in Bandar Tasik Selatan?
- Do you have your own transport?
- How long is your notice period?
Experience:
- Regulatory Affairs: 2 years (Preferred)
Work Location: In person
Application Deadline: 05/20/2025