Job Description

Role Description

General

• Assures the ongoing compliance by reviewing company practices and provide advice on changes to systems.
• Provide regulatory support to currently marketed products as necessary.
• Write or update standard operating procedures, work instructions, or documents related to regulatory requirements.
• Assist QA QMS team on regulatory inspection and audit related to regulatory matters.
• Organize and ensure timely renewal of product registrations and licenses.
• Provide training to related stakeholders on regulatory requirements.
• Maintain good filing and archiving system for easy retrieval.
• Any other task assigns by superior.

Project

• Keep up to date with changes in regulatory legislation, guidelines etc.
• Identify and interpret relevant regulatory requirement. Evaluate applicable laws and regulations to determine impact on company activities.
• Compile and maintain regulatory documentation such as Technical Documentation, Common Submission Dossier Template, Plan Master File etc
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Provide regulatory response to regulatory authorities as required in a timely, proactive, systematic, accurate manner and ensure proper maintenance for new/ existing product licenses.
• Liaising with regulatory authorities and designated agents.
• Review product promotional materials, labelling, storage and packaging requirements for compliance with applicable regulations and policies for new development.
• Provide support to product development for regulatory issues and questions.
• Manage and coordinate Post – Market Surveillance activities including but not limited to FSCA.
• Manage and maintain Chemical compliance database including RMQ assessments.
• Coordinate agreement review on designated agents and critical sub – contractor.

Operation

• Review customer labelling, leaflet and other promotional material for compliance with applicable regulations and policies.
• Prepare and coordinate document require by customer for product registration/ licensing.
• Coordinate review with related stakeholder on QA/ RA Agreement (Importer, Distributor, Authorized Representative).
• Review CS on accuracy prior establish in the system.
• Issuing and maintaining UDI – DI data.
• Ensure timely manner submission for registration in authority database and proper maintenance for new / existing product licenses.
• Manage customer request related to regulatory document (Declaration of Conformity, Chemical Compliance Declaration etc).

Role Requirements

• Minimum 1 years of experience in the field of medical devices and regulatory affairs on medical devices. (can be compensated with education level)
• At least a university degree in scientific discipline.
• English, Bahasa Malaysia, Thai Language.
• Strong in Excel.
• Willing to learn and adapt to changes.
• The candidate must be willing to work in Port Klang, Selangor.

Submit your resume to
hr@karex.com.my
We regret that only shortlisted candidates will be notified.
Thank you and have a nice day!

Job Requirements