Accountability 1: Type Testing Preparation
• Participate on development, approval, and amendments of PTR.
• Support coordination of preparation testing with China and Global teams.
• Support availability of testing samples, jigs and tools and documentation required for type testing.
• Support signature of type testing contract
• Provide input for regulatory strategy related to type testing
Accountability 2: Type Testing Execution
• Coordinate with test centre the testing schedule and sequence, according to registration priorities.
• Conduct testing in test centre following PTR and instructions agreed with test centre engineers.
• Drive resolution of testing issues, including communication with global teams.
• Amend and maintain PTR during the type testing process.
• Maintain and manage Cochlear testing equipment and samples in test centre.
• Get test reports from test centre at completion of testing.
Accountability 3: Regulatory submission and approval
• Support regulatory team regarding technical aspects of Cochlear products
• Coordinate additional testing and related activities for responses to government queries
• Support consultations with NMPA for technical questions or questions related to type testing
Key Incumbent requirements:
• Degree in electrical or electronic engineering
• 2+ years’ experience in regulatory affairs, technical testing, hospital technician or quality control for medical devices, electronic devices or automotive
• Ability to manage stakeholders at all levels within the business and work collaboratively in cross functional teams
• Ability to learn quickly and learn on the job while doing
• Ability to make judgments and provide advice which balances the business interest and regulatory risk.
• Able to make and be accountable for decisions when faced with ambiguity
• Relationship building skills within matrix team environment
• Chinese speaker, ability to read English technical documentation
• Good spoken English level