Senior Complaints Specialist - Med Device
Our client is currently recruiting a number of Senior MDR Vigilance Specialists both Temporary and Permanent position within this function for professionals who are advancing in this area or Clinical / Legal professional looking for a change in direction. Are you a medical or legal professional looking for a complete change. This is a skilled position where you will be challenged and rewarded in the role. Roles are based in Galway
Essentially you would be working in a complaint handling function, which within the Medical Device space is a highly regulated and technical space. In some companies this work resides with a regulatory function, however within our client, you are part of a Quality function. You would be responsible for the review of all experiences that their patients or customers (usually health care professionals/doctors) have.
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 device 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. You will be a dynamic team player who can work effectively and proactively with cross-functional teams. Experience/understanding of complaint handling or CAPA processes is desirable. You must be able to think critically and make sound decisions. You must be focused on patient safety and customer service, set high standards, instills operational excellence, drive accountability and model ethical behavior.
You will be responsible for the oversight of complaint handling activities for a wide range of company products.
You will be responsible for the secondary approval of regulatory reporting decisions in a designated 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 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.
In return - you will be joining one of the top Med Device companies in the world. Career progression is a key part of this client and you will be highly positioned for growth.
If you are interested in this position - please apply with your most recent CV to Bernadette Sisson for immediate consideration