Our client requires a Complaint Reporting Specialist to support complaint handling and regulatory reporting activities for two business units. This is a 12 month contract based in Galway
- To coordinate and support complaint handling of product complaints received by Product Experience Management group.
- To open, track and maintain records for complaints received by Product Experience Management group.
- Data entry into complaint handling system.
- To co-ordinate cross-functional activities in the investigation of customer complaints and determination of root cause.
- To coordinate adverse event reporting per clinical trial protocol requirements and applicable regulations.
- Support of the Vigilance and MDR programs including adverse event reporting, preparing documentation on adverse events and ensuring timely submission with relevant regulatory agencies.
- Develop technical product expertise to assess adequacy of complaint information from the field and review of complaint investigations.
- Support complaint trend analysis and issuance of key reports to relevant departments.
- Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
- Support annual Post Market Surveillance reviews.
- Support responses to Competent Authority queries.
- Understand and ensure compliance with internal procedures and external global regulatory requirements.
- Develop processes and systems in line with best industry practice.
- Actively participate in departmental Continuous Improvement projects
- Support achievement of department goals and objectives
Education, Experience and Skills
- Bachelor?s degree (Level 8 NFQ) in Engineering/Science or related discipline
- 1-2 years relevant experience in a medical devices or related environment.
- Team player who can work effectively and proactively on cross-functional teams.
- Experience/understanding of complaint handling or CAPA processes are desirable.
- Candidates must be a good communicator and are fluent in English, both in writing and speaking.
For further information on this Medical Device Reporting Specialist role in Galway please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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