This position is responsible to coordinate and help prepare document packages for regulatory submissions, internal audits, governmental inspections, recalls, Medical Device Reports and clinical trials.
ESSENTIAL FUNCTIONS PERFORMED
1. Coordinates and prepares document packages for:
- Regulatory submissions (domestic and international)
- Facilitates corrective actions on internal audits
- Governmental inspections
- Recalls
- Medical Device Reports
- Clinical trials
- Company policies and procedures
2. Interacts, as directed, with various levels of management, external agencies and companies.
3. Participates on project task teams.
4. Performs other related duties and tasks, as required.
