QA, International Vigilance Specialist
Reporting to Vigilance Manager, EEA & MEATI.?
Overall Purpose of the role:
Reporting to the Vigilance Manager, EEA & MEATI and acting as a key member of the International QA Department. The Vigilance Specialist is responsible for ensuring that our client meets its Regulatory obligations under the Post Market Vigilance and Field Safety Corrective Action requirements of the Medical Device Directive (MDD) and Medical Device Regulations (MDR) within the EEA and comparable reporting responsibilities in other countries in MEATI region.
Applicants should ideally have at least 5 years’ experience of working within a highly regulated environment (preferably healthcare) and have experience in communicating with government or statutory authorities.
They will also have significant complaint handling experience and a quality process focus. The work environment is a changing, dynamic environment, where a need to adapt to change easily, show flexibility, prioritisation, organisation and time management skills are a pre-requisite.
Applicants should ideally have a working knowledge of fundamental healthcare-related processes and be able to prepare and review detailed responses to Competent Authorities for completeness, relevance and accuracy.
Essential criteria for the position are:
- Knowledge of Quality Systems (ISO 9001, ISO 13485, QSR), Medical Device Regulation (2017/745) Medical Device Directive (93/42/EEC), FDA (US CFR).
- Good IT Skills and ability to work with MS Office, along with Corporate Information and Documentation Systems (eg Agile, EtQ, SAP, JDE).
- Excellent organizational skills, with meticulous approach to filing and storage of documentation, and ability to follow-up in ensuring that status-reports, procedures, and other relevant documents, are kept fully up to date.