Regulatory Affairs (RA) Executive (Manufacturing based in Kuala Lumpur)

Job Description 

• 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)