Our client, a medical device company in Galway are currently looking to recruit a MDR/Vigilance Specialist for their site.
- You will be responsible for the oversight of complaint handling activities for a wide range of products.
- You will be responsible for the secondary approval of regulatory reporting decisions in a designate role.
- You will also be responsible for the timely submission of US MDR and EU Vigilance Reports to external regulatory agencies.
- You will also support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
- You will also provide oversight of clinical trial activity with respect to complaint handling, and provide appropriate support to the clinical teams as required, including interaction with clinical safety teams.
- You will support complaint trend analysis and annual post market surveillance reports for various products.
- You will also support complaint handling harmonization initiatives with other company sites globally.
- You will support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
- You will also support both internal and external audit activities and will interface directly with auditors/inspectors.
- You will also support any CAPA activities as required.
- You will also directly manage people and be responsible for communication and coordination of talent management initiatives with reports.
- You will contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department.
- You will also lead problem solving initiatives within the department and coach or mentor other team members.
- We are looking for a qualified person to Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline and preferably with 5-8 years relevant experience in a medical devices or related environment.
- Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
- We are looking for a dynamic 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 able to think critically and make sound decisions.
- Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour.
- Candidates must be a good communicator and are fluent in English, both in writing and speaking.
For further information on this MDR/Vigilance Specialist role in Galway please contact Caroline Kingston on 0868395531 / firstname.lastname@example.org
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