At our Product Experience Management (PXM) group, which is part of the Galway PXM Complaint Handling and Regulatory Reporting Department, we focus on complaint handling and post market regulatory reporting activities for a wide range of products. You will lead a high performing Complaint Handling and Medical Device Regulatory reporting team, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance.
- Contribute to planning, directing and implementing all aspects of the complaint handling
- Oversight of a team responsible for the completion of global regulatory reporting decisions Responsible for Key performance indicator management including the timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external regulatory agencies
- Manage the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports
- Support complaint handling harmonization initiatives
- Have oversight of support of risk management, risk analysis and health hazard analysis associated with complaint/post-market information
- Manage continuous improvement activities within your team including the role out of cell operating systems and principles within the PXM department
- Responsible for People management activities and enabling the development of team members.
- Our client is 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
- Good communicator and fluent in English, both in writing and speaking
Leadership Expectations provide the framework for what we expect from all employees outlining the actions and behaviours we must develop and demonstrate in pursuit of our Mission and global growth goals.
- To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent