Our client, a leading medical device company in Galway are looking for Associate MDR/Vigilance Specialist to join their team on a 12-month contract.
This position is a part of the Product Experience Management group (PMX) where you would be focusing on compliant handling and post market regulatory reporting activities.
This role reports to the Reporting into the Quality Manager in the PMX Group.
Responsibilities may include;
- Co-ordination of complaint handling activities for a wide range of products including receipt and documenting of incoming complaint events.
- Response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports
- Co-ordination of cross-functional activities in the investigation of customer complaints and determination of root cause.
- Risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
- Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs) and Adverse Drug Experience (ADE).
- follow- up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
- Liaise both internally and externally to develop programs and processes to meet regulatory reporting requirements.
- Bachelor’s degree (Level8 NFQ) in Engineering/Science or related discipline.
- 1 -2 years relevant experience in a medical devices or related environment.
- Will consider applicants with legal or clinical qualification.
- Experience/understanding of complaint handling or CAPA processes are desirable.
- Excellent communication skills both written and verbal.
- Team player who can work across cross functional teams.
If you are interested in applying to this role please send an updated CV to Rebecca O'Connor at ROconnor@sigmar.ie or call 091 749265 for confidential chat.
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