Regulatory Affairs Specialist

2 weeks ago


Subang Jaya, Malaysia Sysmex (Malaysia) Sdn Bhd Full time

**Roles & Responsibilities**:

- Submit new product registration of medical devices and reagents and ensure submissions are done in a timely manner.
- Engaging with government bodies such as the MDA (Medical Device Authority) to ensure compliance with local guidelines.
- Regular reporting on registration status to management.
- Keeping up to date with changes in regulatory legislation and guidelines.
- Responsible for managing and maintaining ISO Quality System and documentation.

**Requirements**:

- A Diploma/Degree in Biotechnology, Biomedical Science, Pharmacy, Regulatory Affairs or equivalent. Fresh graduate are welcome to apply.
- Preferably with minimum 3 years of related working experience in clinical laboratory or regulatory affairs in medical device or pharmaceutical company.
- Experience dealing with Medical Devices Authority (MDA) on product registration submission.
- Has basic knowledge in ISO 9001/GDPMD standards.
- Possess own car.
- Sysmex (Malaysia) Sdn Bhd
11A & 15 Jln PJS 7/21, Bdr Sunway, 47500 Subang Jaya, Selangor



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