1. Ensuring Company’s products comply with the regulations of Medical Device Authority
2. Ensuring the Good Distribution Practice for Medical Devices (GDPMD)
3. Regulatory Compliance System is established, implemented and maintained.
4. Reporting to top Management on the performance of the GDPMD Regulatory Compliance System, as well as to idenify and correct deviation, if any from the establised GDPMD regulatory compliance system.
5. Ensuring the awareness on obligation to complywith regulatory requirementsand any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.
6. Liaise with external parties on matters relating to the Malaysian medical device regulatory requirements.
7. Developing clear explanation for new product licence and licence renewals.
8. Preparing submissions of licence variations and renewals to strict deadlines.
9. Monitoring and setting timelines for licence variations and renewal approvals.
10. Writing clear, accessible product labels and patients information leaflets
11. Planning and developing product trials and interpreting trials data.
12. Advising manufacturers/vendors/suppliers on regulatory requirements.
13. Providing strategic advice to senior management throughout the development of a new product.
14. Project managing teams of colleagues involved with the development of new products.
15. Undertaking and managing regulatory inspections.
16. Reviewing company practises and providing advice on changes to systems
17. Specifying storage, labelling and packaging requirements.
18. Manage and handle day to day office administration and general affairs such as office maintenance, office equipment leasing, mails, answering to phone calls, corresponding to emails, equipment maintenance, office refreshments, printing matters, mails collection, courier and ad-hoc duties being assigned.
19. Multi-tasking assing by Management on adhoc basis
Perks & Benefits
- Snacks and refreshments
- Regular team activities
- Parking Allowance
- Medical insurance
- Personal leave
- Personal development opportunities