Clinical Development Medical Manager overseeing execution and interpretation of clinical trials and data collection activities in China. Leading collaborations with stakeholders to ensure clinical research efficiency.
About the role
- Manage Quality for medical equipment in a hybrid setting. Oversee compliance, regulatory issues, and continuous improvement projects while ensuring customer satisfaction.
Responsibilities
- Manage the quality and compliance for applicable products and processes
- Ensure quality and regulatory compliance with applicable regulations
- Act as a liaison with Divisions, Suppliers, Manufacturing, and/or Operations
- Manage complaints and develop new approaches to solve problems
- Identify and manage the execution of continuous improvement projects
- Assist in the planning of design, testing, inspection, and process validations
- Ensure all quality issues are resolved to customer satisfaction in a timely manner
Requirements
- Bachelor’s degree in Engineering, Science, or Technical Field
- At least 4 years of experience related to the design/operation of medical device or drug combination product platforms
- Knowledge of QSR/GMP/ISO requirements or other regulated industries
- Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR)
- Proficiency in analyzing and reporting data
- Advanced level skill in Microsoft Excel
- Position requires travel up to 25% of the time for business purposes
Benefits
- health insurance
- life and disability
- 401(k) contributions
- paid time off
- continuing education & training
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