Quality Compliance Assistant
1 month ago
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
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