- Individual must ensure that the requirements for post market surveillance reports are met through creating reports.
- Should obtain data such as Risk Assessments, Clinical Evaluation Reports, Complaints, Vigilance, Medical Device Reports, CAPAs etc. by working with the cross functional teams.
- Individual must plan, implant and ensure compliance to Medical Devices regulatory programs.
- Coordinate activities/tasks and resources across affected departments.
- Responsible for supporting a Regulatory Affairs program.
- Coordinates and manages small to medium scope projects.
- Work direction is provided and is generally supervised and reviewed by more senior staff.
- Lead cross-functional teams and Project Management experience is plus.
- Minimum of 5 Years of Experience.
- Expert in writing Post Market Surveillance (PMS) Report, Medical devices.
- Expert in sustaining updated reports through the in-house tracker.
Job Type: Contract
- Medical Devices regulatory programs: 8 years (Preferred)