Regulatory Affairs

3 days ago

Kuala Lumpur, Kuala Lumpur, Malaysia Talent Recruit Full time


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)

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