Compliance
New Product Development
Ensure essential design control processes are in place to support new product development and design changes
Support the creation of necessary quality deliverables in product development processes
Regulatory Compliance
Perform internal audits of existing procedures and processes to identify areas of risk
Respond to regulatory agency requests and enforcement action
Prepare teams for FDA and international regulatory agency inspections
Prepare/edit applicable operating procedures, work instruction and forms
Develop and implement strategies for maximizing compliance profile
Training/Coaching
Develop training presentations and conduct employees training sessions on new and existing regulatory requirements