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Regulatory Engineering Specialist

Apply now Job no: 615002
Work type: Permanent
Location: Jinan
Categories: Quality & Regulatory, Asia Pacific, Individual Contributor

Accountabilities:

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:

Minimum:

• 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

Ideal:

• Good spoken English level

Advertised: China Standard Time
Anticipated Application Closing: China Standard Time

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