Responsibilities:

• 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.

Requirements:

• 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

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