Sr Manager, Regulatory Affairs

Job Description

Main Tasks & Responsibilities

• Develop and implement competitive registration strategy for medical and life science products such as medical device, IVD, animal health/human identification products, etc.
• Make sure the registration activities and submissions are done in an accurate, timely and cost-efficient manner.
• Closely liaise with regulatory authorities including but not limited to NMPA, PMPA, Ministry of Public Security and Ministry of Agriculture, to optimize the advancement of product registration activities.
• Establish and maintain cross-function communications to make project team fully aware the regulatory requirements and the supports needed; efficiently solve issues to achieve project goals.
• Work with 3rd party partners with direct negotiations and liaisons, provide regulatory inputs for partnership/OEM/license in/license out when necessary.
• Monitor regulatory environment changes, proactively and accurately assess and interpret regulatory requirements and impacts.
• Manage and develop team members to support the growing business team.
• Support labeling and quality projects; handle other tasks assigned by line manager.

Qualification

• Bachelor’s degree or above, major in medicine/biology/bio engineering/pharmaceuticals or related fields
• Excellent knowledge and competency in medical device/IVD registration, traceable experience in successful registration projects in both imported and domestic Class II/III devices after 2014 is preferable.
• 10+ years of experiences in medical device/IVD industry, with more than 5 years in management role
• Experience in leading successful team and projects. Excellent skills in multi-task management, problem solving and creative thinking.
• Able to work under pressure.
• Excellent written and verbal communication skills in both Chinese and English. Advanced computer skills in Office software