Regulatory Affairs Manager

Mission

This position will report to the Country Manager in China. He/she will independently perform and manage regulatory activities within a highly regulated, fast-paced industry to ensure that company objectives are achieved in compliance with regulatory requirements. He/she masters the relevant local regulations in China, he/she is able to select and collaborate with appropriate local representatives to obtain product registration and/or clinical trials clearance. The regulatory affairs manager develops and adapts the regulatory processes and associated procedures & tools according to applicable regulations. He/she is able to train the IBA staff and address any auditors questions on regulatory processes.

Challenges we trust you with

• Manage complex regulatory projects:
- Ensure consolidated technical files meet the regulatory requirements and are kept up to date. 
- Compile and submit complex regulatory submissions to regulatory authorities and notified bodies. 
– Coordinate the preparation and the delivery of reviewing responses to regulatory authorities and notified bodies. Maintain registration information (license numbers, certification declaration, etc) and obtain re-registration approvals in advance of license/certification expirations.
• Identify laws, regulations, standards and guidance applicable to the organization in the target markets as defined by the management and according to the product specificities.
• Ensure regulatory compliance with applicable standards, directives and regulations.
• Meet with Regulatory Agencies/Competent Authorities to organize pre-survey deliverables and pre-survey submission strategy. Identify potential risks in submissions and anticipated regulatory responses through scenario planning.
• Communicate Regulatory requirements throughout the organization as appropriate and train IBA staff to regulatory processes as necessary.
• Develop and adapt the Regulatory processes and associated procedures & tools according to applicable regulations and IBA business expansion.
• Explain the regulatory processes during internal and external audits/inspections.
• Review and approve marketing and promotional materials and other types of external communications for compliance with regulatory requirements.

What we value

•    Bachelor degree in bioscience /engineering or a comparable combination of education and experiences; 
•    >10 years regulatory experiences in MNC medical device company, radiotherapy industry preferred.
•    Demonstrates profound knowledge and expertise in medical device regulations in China; 
•    Proactively and accurately assesses and interprets regulatory requirements and impacts and timely feedback to relative counterparts; 
•    Knowledge on innovative medical device faster approval application;  
•    Experiences in complex regulatory activities, effectively and efficiently facilitates the discussions with regulatory authorities; 
•    Good communication skill, fluent in English &Chinese.
•    Knowledge in clinical trial and/or Good Clinical Practices (GCP) is an asset