PMD is #MakingEveryBreathCount improving patient outcomes & safety with RespiraSense, a revolutionary sensor platform for continuous respiratory rate monitoring

Making Every Breath Count!

At PMD we have a moto that sums up our intent and the premise on which our company was established…..

Making Every Breath Count!

Careers at PMD Solutions

Position

Quality & Regulatory Affairs Associate

Role Description

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.

Role Responsibilities

  • Responsible for the distribution, retrieval, and filing of controlled documents (SOPs, Forms, etc.) as well as other Quality documents;
  • Oversee document control within all departments and ensure all standard procedures are updated as required;
  • Ensure that quality records are filed and stored and retrieved in accordance with record retention policy /procedures;
  • Assist with international market regulatory activities, i.e. regulatory requirement research, impact/gap/risk analysis, device/product registrations
  • Document and report issues to management in order to ensure corrective actions are implemented;
  • Responsible for organizing the filing, collection, scanning and storage of all Quality, Device History, Records/Logbooks for all PMD projects;
  • Collating & trending of Quality Objectives trend data;
  • Scheduling of Quality Meetings and recording of Minutes;
  • Trending/analysis of Quality Data;· Assist in the development, analysis and improvement of site Quality Metrics;
  • Support internal audits, CAPA, and Complaint/MDR/Vigilance activities.
  • Participate in our corrective action program and continual improvement projects;
  • Assist in labeling review a to ensure regulatory compliance.
  • Other related quality tasks as required.

Background and Experience Required

  • A Bachelors Degree in an appropriate discipline
  • 1 years industrial experience working in an ISO9001, ISO13485, GMP or other appropriate quality, administration or document control position.
  • Postgraduate training in Quality Management would be advantageous
  • Medical device or pharma background would be advantageous.
  • Experience of carrying out internal audits would be advantageous.
  • Strong interpersonal skills and the ability to collaborate with various teams.
  • Excellent written and verbal communication skills in the English language is essential.
  • Strong computer skills (MS Excel, PowerPoint, Word etc.).

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.

Job Type: Full-time

Application via email to:

info@pmd-solutions.com