Reporting & Corrections Manager

The Reporting and Corrections Manager is responsible for effectively managing the regulatory reporting process for medical device complaints in accordance with US and international regulations and Varian procedure. In addition, the Reporting and Corrections manager will be responsible for coordinating and reporting recalls, corrections, field withdrawals and other post-market corrective action. The Reporting and Corrections manager will write and maintain standard operating procedures which meet regulatory requirements and interlock with supporting procedures of other VOS departments such as Service. The manager will be responsible for standard department activities including budgeting, staffing and administration. This position is responsible for applying reporting and corrections requirements to all VOS products except Brachytherapy. The position works closely with Complaints, which receives and investigates medical device complaints, and CAPA, which coordinates the corrective action arising from completed complaint investigations. This position has very high visibility to top Varian management, the Board of Directors and regulatory agencies. Overall Responsibilities:1. Handle the reporting and corrections arising from medical device complaint files in accordance with 21 CFR, Canadian regulations, European Directives.2. Manage the documentation of all complaints (MDR, MPR, Vigilance, etc) which require reporting to the various regulatory agencies of jurisdiction where the products are located.3. Maintain a timely process which meets or exceeds requirements Medical Device Reporting (MDR) in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting and any other worldwide regulatory requirements. 4. Maintain and improve electronic applications which support regulatory reporting and recall tracking and documentation. 5. Provide for tracking and reporting of corrections and removals to FDA and other agencies. 6. Assist in the creation of customer communications of corrections and removals. 7. Provide trending and analysis of corrections and removals8. Report to senior management on the need for and status of corrections and removals.9. Work with worldwide regulatory agencies on inquiries regarding complaints, device reports and recalls. 10. Assist with regulatory agency inspections. 11. Coordinate with other departments including service, marketing and Engineering. 12. Manage a team of specialists to complete timely reporting.13. Develop training programs to train this and other departments in the company about the applicable regulations and procedures.14. Coordinate the effort for the determining the potential of a product correction and /or removal and alert upper management.VARIAN MEDICAL SYSTEMS is firmly committed to a policy of equal employment opportunity and will administer its Human Resources policies and conduct its employment practices in a manner that treats each employee and applicant for employment on the basis of merit, experience, and other work-related criteria without regard to race, color, religion, sex, national origin, ancestry, sexual orientation, age, marital status, medical, disability (mental or physical), veteran status, or any other protected class under relevant state and federal laws. For this position reply to: Varian Medical Systems