Title: Assoc MDR/Vigilance Specialist
Duration: 23 months
Location: Work from home / Galway
Start Date: ASAP
Main Duties and Responsibilities:
(Responsibilities may include the following and other duties may be assigned)
* Part of a team responsible for the management of all incoming product events from a range of sources and geographies. * Responsible for the data entry of field complaints reported for medical devices into complaint database, including documentation review and complaint assessment. * Support Vigilance and Medical Device Report (MDR) regulatory reporting by ensuring timely assessment of incoming complaint events. * Support complaint trend analysis and issuance of key reports to relevant departments. * Contribute to continuous improvement activities to support efficiency and productivity gains opportunities within the PXM department. * Build product knowledge and technical expertise of the product group you support. * Adherence to procedures at all times to ensure compliance. * Ensure highest quality of product event data entry for accuracy of reporting to regulatory agencies.
KEY SKILLS & EXPERIENCE
* Bachelor's degree in Science or related discipline
* 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.