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Mission:Coordinate the execution of regulatory submissions for the registration of domestic IVDs and medical devices in China, in respect of timelines and regulatory strategy agreed with program governance and Corporate functions
Identify applicable regulatory requirements (including changes to existing ones) and guide local compliance and implementation
Responsibilities:
Manage the assigned regulatory team, ensuring leadership and coordinating related activities
Oversee and manage the execution of regulatory activities for the registration of domestic IVDs and medical devices in China, cooperating with the relevant departments and Corporate functions
Maintain direct contact with Authorities and Regulatory bodies (primarily, SHMPA) for product registration activities; act as point of contact for queries and communication
Maintain compliance with relevant statutory, regulatory and industry best practices
Ensure the preparation of the technical documentation for market registration as domestic IVDs in China
Collaborate with various key Functions to direct regulatory issues to appropriate existing channels for investigation and resolution (e.g., Marketing, Commercial, Operations, Quality Assurance, R&D)
Requirements:
University degree in Biology, Chemistry, Pharmacy, Engineering, or equivalent
Minimum 7 years of experience in similar roles in the health care and sciences industry, preferably with diagnostics and medical devices
Detailed knowledge of statutory and regulatory requirements applicable to the field of medical devices and IVDs in China for domestic products
Basic working English (fluency a plus)
Previous experience in registration of domestic IVDs with SHMPA and successful track record
Experience on both assays and instruments a plus
Direct relationship with SHMPA for registration in past experiences a must
Previous experience as line manager
Located (or able to relocate) near Baoshan (office presence a must)
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