Regulatory Affairs & Labeling Specialist

Morgan Mckinley

Tipperary

Job Duties & Responsibilities: Generation, reviewing and release of 'Customer facing documentation' (i.e. Instruction for Use, XML generation, webpage maintenance etc.) Instructions for use. XML files. Rilibäk Guidelines. Lot Confirmation Documentation. Kit & Vial Labelling. Control, distribution and administration of Quality and Regulatory documentation which support the company's quality management systems. Process and approve document change requests followed by providing notification of changes to controlled documents to relevant parties. Support tasks to deliver for CE marking activities as required to IVD directive. Support product registration and notifications. Provide regulatory documentation and certifications upon request. Support generation of documentation for product registration outside the European Union. Provide, as required, regulatory input and approval for changes and classification of changes to all documents impacting the QMS. Assisting in preparing and maintenance of Technical Files for product registration and submissions to EU and International Competent Authorities and / or Regulatory Agencies. Input in to Post Market Surveillance and Risk Management processes. Provide support to Manufacturing QA, R&D Quality and Quality Systems areas from a quality perspective as required. Conduct internal quality system audits. Other duties as required to support the quality systems. Demonstrate an understanding of the application of the Quality Policy through daily activities. Maintain vigilance to ensure adherence to the Quality Policy and system procedures by promptly reporting noncompliance issues to management. Performs other related duties as assigned by management. Qualifications/Competencies: Minimum of degree qualification in a relevant Science, Engineering or Quality Assurance discipline. 4 years industry experience working in a regulated medical product environment. Good knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC and international regulatory requirements. Familiar with ISO 14971. Strong interpersonal skills and the ability to communicate well - verbally and in writing - with others. Excellent attention to detail and ability to prioritise. Morgan McKinley is acting as an Employment Agency in relation to this vacancy. Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide. This job originally appeared on RecruitIreland.com.

2389 days ago