Job Title: Quality and Regulatory Assistant
Brief Role Description: We are seeking a detail-oriented and proactive QARA Assistant to support the Quality Assurance and Regulatory Affairs functions of our medical device distribution business. The QARA Assistant will assist in maintaining compliance with applicable regulatory requirements (e.g., FDA, MDR, ISO 13485), manage documentation, support audits, and help ensure quality systems are effectively implemented across the organisation. The Quality and Regulatory Assistant will support the Quality and Regulatory Team in maintaining an accurate and effective Quality Management System (QMS) in accordance with medical standards.
Date: May 2025
Reporting To: Head of Quality & Regulatory Affairs
Hours per Week: Full Time
Location: Ireland Offices
Responsibilities:
* Assist with document completion, online record storage, maintenance and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485, ISO 9001, ISO 14001 and other applicable standards.
* Coordinate and maintain controlled documents, including Quality Assurance Procedures (QAPs), work instructions, and policies. As part of the QARA team, be involved in the approval process for new and amended QAPs, ensuring new and superseded documentation is correctly filed.
* Support the complaint handling process by logging, investigating, and following up on product complaints.
* Track and report on corrective and preventive actions (CAPAs) and assist in implementing improvements. Assisting with the Non-conformance process and ensuring target deadlines are met.
* Prepare documentation and support internal and external audits (e.g., ISO certification, regulatory inspections).
* Maintain records and databases for supplier qualifications, training, product traceability, and regulatory submissions.
* Ensure all labeling and promotional materials are compliant with applicable regulatory standards.
* Supporting managers with completion of Initial Training records and all mandatory QAP training
* Goods inward quality inspection
* Assisting with Osteotec devices technical files and ensuring records are updated accordingly
* Data collection from QMS and analysis, to aid continuous improvement
* Collaborate with sales team and customer services to gain post-market feedback
* Gather information and review PMS report periodically
* Assisting with Internal Audit organisation and reporting
* Any other relevant, reasonable ad hoc duties that may be requested
Essential:
* A Degree in any relevant scientific discipline
* A high level of attention to detail and ability to follow procedures accurately
* Excellent written and verbal communication skills
* Highly organised and able to work alone when required
* Proficient with Microsoft Office (Excel, Word, PowerPoint, Outlook)
* Previous experience in quality management or regulatory affairs in medical devices, pharmaceutical or food industry
* An ambition to develop a career in a QARA function in the medical device industry
* Ability to work independently, manage multiple priorities, and maintain attention to detail.
* Effective written and verbal communication skills.
Highly Desirable:
* Experience in regulatory affairs or in quality management systems relating to medical devices.
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