Head of Regulatory Affairs and Quality Assurance

Responsibilities:

• Lead the Regulatory Affairs and Quality Assurance function for Waters Shanghai China business
• Establish QMS system for Legal Agent and Marketing Authorization Holder to ensure compliance with medical device registration certificates and product technical standards (draft and implement policies and procedures such as labeling, adverse event monitoring, recalls, internal audits and future filing of annual MAH self-inspection reports to the relevant supervision authority)
• Liaison with National and Provincial medical device competent authorities in China such as National Medical Products Administration
• Monitor and advise organization of prevailing and evolving China and other APAC medical device regulatory requirements
• Influence China regulations that impact Waters business by responding to requests for public comment and by participating in CMDE, NIFDC, BIMT and other agency development of product specific technical review guidance and product technical standards affecting Waters medical devices
• Direct Waters China and APAC promotional policies and practices
• Participate in due diligence and integration activities of domestic or foreign acquisitions that have regulatory implications
• Facilitate (host) NMPA audits, conduct internal audits of Legal Agent and Marketing Authorization Holders, and support 3^rd party audits
• Future UDI database maintenance, including uploading, maintaining, and updating relevant data relating to medical device products

Qualifications:

• Bachelor’s degree required preferably in science or engineering. Advanced degree preferred.
• Extensive understanding of medical device regulations in China and in other key APAC markets
• Experience and proven success in planning and implementing regulatory strategic plans for China and other APAC
• Highly developed intercultural competence/awareness
• Excellent fluency in English and Mandarin
• Experience in developing positive relationships with high level government authorities
• 7+ years combined direct medical device regulatory affairs and quality assurance and inspections experience in China for registration of medical devices - experience must include management of type testing, preparation of registration applications and interaction with regulatory authorities
• Proven success achieving medical device registration of IVD reagents, electrical instruments and software in China under Decree Number #650 published March 2014
• Knowledge of IEC, GB, YY standards a plus
• Managerial experience a plus
• Ability to manage and influence within a matrix organization
• Leadership skill in articulating a vision and moving an organization forward to achieve its goals and objectives