Quality & Regulatory Affairs Associate
PMD Solutions is seeking to recruit a Quality & Regulatory Affairs (Q&RA) Associate. As the Q&RA Associate, you will assist the Quality Manager in maintaining compliance with ISO 9001, ISO 13485 and other global regulatory requirements (e.g. 21 CFR 820) within the company.This individual performs assigned tasks and responsibilities including Quality Management System (QMS) document control, assisting with medical device and product registrations, participating in the preparation and maintenance of Technical Files/DHFs, maintaining QMS documents, assisting internal audit, performing regulatory research and impact analysis, as well as handling Complaint/MDR/Vigilance.
This position requires a professional individual with meticulous attention to detail, strong reporting and communication skills and high levels of organisation.
This is a full-time permanent position based in Cork city, Ireland.
Note: This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the job. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned.