Quality Compliance Assistant

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.

Salary: From RM1.00 per month

Benefits:

• Free parking
• Health insurance
• Maternity leave
• Parental leave
• Professional development

Schedule:

• Monday to Friday

Supplemental pay types:

• Performance bonus