Description
MDR Specialist/ Complaints SupervisorSUMMARY
Experience in complaint management/regulatory reporting in the quality/manufacturing and medical device industry, including vast knowledge of 21CFR 820 and 21 CFR 803 Medical Device Reporting (MDR), ISO 13485 and MDD and Vigilance Reporting andCanadian Problem Reporting SOR/98-282
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Provide guidance to the team regarding the complaints to ensure appropriate action and closure.
- Ensure timely submission of MDR and vigilance reports
- Conduct product and complaint investigations with follow-up as required for associated CAPAs.
- Responsible for receiving, investigating and documenting product complaints
- Responsible for oversight of Medical Safety Reviews and patient safety failure investigations
- Conduct reviews and provide monthly reports for department metrics
- Write and/or revise procedures/work instructions.
- Provides technical support to the team (projects, reports, etc)
- Support internal, external, and third-party audits.
- Support technical needs of the department.
- Assist with Health Hazard Analysis and participate in Quality Review Board, as required
- Train employees in SOP's and ensure training effectiveness in application of job skills
KEYWORDS: QA, RA, quality assurance, regulatory affairs, MDR, complaints analyst, investigations, medical device, san diego, carlsbad, irvine
To find out more about Real please visit www.realstaffing.com