Telephone: 086 8395533
PXM MDR/Vigilance Manager
Our client, a medical device company in Galway are currently looking to recruit a PXM MDR/Vigilance Manager for their site.
- You will contribute to planning, directing and implementing all aspects of the complaint handling activities for a wide range of products.
- You will have oversight of a team responsible for the completion of global regulatory reporting decisions.
- You will also be responsible for Key performance indicator management including the timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external regulatory agencies.
- You will manage the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
- You will also support complaint handling harmonization initiatives with other sites globally.
- You will have oversight of support of risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
- You will manage continuous improvement activities within your team including the role out of cell operating systems and principles within the PXM department.
- You will also be responsible for People management activities and enabling the development of team members
- We are looking for a qualified person to Bachelors / Masters Level in a relevant Technical qualification and desirably with 9-13 years relevant experience with a BSc and 7-11 years’ experience with a Masters.
- Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
- People management experience in leading a team is essential.
- We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams and cross site 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.
- You are a good communicator and fluent in English, both in writing and speaking.
For further information on this PXM MDR/Vigilance Manager role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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