- Managing regulatory affairs activities for company including products registration and other approvals required to conduct current and future business activities.
- Liaise with teams to develop plans, cost estimates, and acquiring the necessary permits and other approvals.
- Establishing a close professional relationship and maintaining active dialog with relevant health authorities
- Ensuring regulatory and quality assurance compliance according to SOPs.
- Plan, lead and maintain GDPMDS program as the Management Representative to meet with QMS qualifications.
- Degree in Biomedical Engineering or equivalent
- Minimum 3 years of experience in RA management in Medical Device industry
- Experience in GDPMDS and possess knowledge of Medical Device Regulations
Song Zhaohui EA License No. 02C3423 Personnel Registration No. R1761205