Role DescriptionGeneralAssures the ongoing compliance by reviewing company practices and providing 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 assigned by superior.ProjectKeep up to date with changes in regulatory legislation, guidelines, etc.Identify and interpret relevant regulatory requirements.
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.Liaise with regulatory authorities and designated agents.Review product promotional materials, labeling, 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 subcontractors.OperationReview customer labeling, leaflets, and other promotional material for compliance with applicable regulations and policies.Prepare and coordinate documents required by customers for product registration/licensing.Coordinate review with related stakeholders on QA/RA Agreement (Importer, Distributor, Authorized Representative).Review CS on accuracy prior to establishing in the system.Issue and maintain UDI-DI data.Ensure timely submission for registration in authority database and proper maintenance for new/existing product licenses.Manage customer requests related to regulatory documents (Declaration of Conformity, Chemical Compliance Declaration, etc.
).Role RequirementsMinimum 1 year 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 a scientific discipline.Fluency in English, Bahasa Malaysia, and Thai Language.Strong proficiency in Excel.Willingness to learn and adapt to changes.The candidate must be willing to work in Port Klang, Selangor.Submit your resume ******
We regret that only shortlisted candidates will be notified.
Thank you and have a nice day!#J-18808-Ljbffr