We are delighted to present this opportunity for global medical technology client, who is looking to recruit a Vigilance Specialists
As a Vigilance Specialists you will be responsible for:
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 Client 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
As a Vigilance Specialists you must 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 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.