This position is responsible for the preparation and maintenance of international regulatory filings to meet corporate objectives, and for the timely completion of other assigned activities related to regulatory support activities worldwide.
Plan and direct performance of staff members as assigned: Motivate employees, assist in goal setting, provide development opportunities and performance feedback, address complaints and resolve problems.
Lead implementation and infusion of quality engineering tools throughout the organization to drive methodical and process-based approaches to product and process development. Utilize same approach to existing products and processes, applying where possible, new technologies and methods.
Oversee clinical management for premarket trials and post-approval studies, and registry studies, including protocol development/training, CRO management for database management/Electronic Data Capture (EDC) and bio statistical analysis, site monitoring, and timely reporting.
Developing and writing responses to customers for product complaints. Take complex medical procedure information and determine the course of events related to each complaint and write investigation findings in response to customer inquiries.
Responsible for developing and conducting global clinical trials/studies on products and for ensuring compliance with global regulations governing conduct of clinical research and internationally recognized standards.
The Supervisor oversees quality record archival and training tracking, and manages and implements the processes associated with the creation of new, and revision of existing, documents throughout the complete product lifecycle in a regulated medical device company.
Understands and supports the company's policies and procedures as it pertains to product complaint handling and required regulatory reporting. Meets monthly, quarterly, and annual sales quotas established by company.