Prepare and collate required documentation to support submissions for product approval and maintenance (e.g. Variations to Marketing Authorisations, MDA etc)
Maintain efficient scheduling of regulatory licenses maintenance and renewals and support Competent Authority audits to the licences.
Support the timely registration of all current and new products with the correct regulatory authorities.
Responsible for advising/supporting internal SMEs to assure the continued Regulatory Compliance of existing products throughout their life cycle
Review proposed marketing materials, packaging, Instructions For Use and Label copy for Regulatory compliance to MDA and to the appropriate requirements for ROW markets.
Setup packaging labels for Owen Mumford Sdn. Bhd, ensuring the labels comply to the appropriate labelling requirements for relevant markets.
Maintain the electronic product packaging artwork folder to ensure it is always up to date and organized.
Maintain effective and efficient administration of Change Control for Owen Mumford Sdn. Bhd.
Maintain good documentation filing system of Design Transfer Files for products/projects that are being transferred from Owen Mumford Limited.
Any other activity as directed by the Regulatory Affairs Officer or Site Quality Manager.
Report to Regulatory Affairs Officer on progress with activities, provision of metrics and other information (e.g. input to Weekly /Monthly Quality / RA Reports) and escalation of issues.
Comply with Owen Mumford policies and procedures and fulfil roles and responsibilities as defined to support full compliance.
Complete work to agreed priorities and meet due dates. Report to those in authority if any timelines are likely to be missed.
Listen to performance feedback provided and takes any necessary improvement action.
Complete personal Training and Development Plan and seek opportunities to grow and learn.
Job Type: Full-time
Benefits:
Health insurance Professional development
Schedule:
Supplemental pay types:
Application Deadline: 04/30/2024
Expected Start Date: 04/15/2024
