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Job Title

Regulatory And Quality Manager


Morgan Mckinley




An exciting opportunity for a Quality and Regulaotry Affairs Manager to join an Irish IVD company who develop and manufacture all products at their purpose built state of the art facility. The products are sold in over 100 countries globally. Reporting to the CEO, you will be the SME for all Quality and Regulatory requirements. As the Quality and Regulatory Affairs manager you will provide direction and leadership for the development, implementation, communication and maintenance of quality system policies and procedures for the Company in accordance with ISO 13485:2003 and IVDD regulatory requirements. Responsibilities; Responsible for applying and maintaining a compliant Quality System per ISO and FDA requirements. Represent the company during regulatory agency audits and inspections. Responsible for strengthening the quality systems and for determining the appropriate infrastructure and resources required to achieve the company's objectives. Provide leadership and strategic direction to the quality function and ensure proper interface to Manufacturing, Distribution, Research and Development, Marketing and Sales. Advance the company's growth and adherence to industry standards for product assurance, validations, design controls, document and data controls, supplier management, statistical techniques, etc. Support the development of strong relationships with major customers through the achievement of highest quality standards. Development and Implementation of appropriate Supplier Quality programs. Responsible for regulatory compliance with: ISO, Notified Bodies, FDA and other foreign regulations. Acts as the Quality and Regulatory authority to the company as needed. Create and maintain regulatory submissions domestically and internationally. Monitor and assurance of compliance of all products manufactured and distributed. Provide support on compliance and quality assurance decisions for: Operations, R&D, Sales and Marketing and Executive Management. Provide direction for the Management and Quality team members to develop and achieve objectives and achieve compliance to QMS requirements. Ensure the QMS is maintained and effective. To advise and provide input to improve the effectiveness of the quality management system. Ensure compliance with Pre Market, Post Market and Vigilance guidance and requirements. Lead and represent management at on site audits carried out by regulators, external agencies or customers including co-ordination, implementation, and follow up for regulatory agency audits. Assure quality contributions, which enhance integrity of products or processes in meeting requirements. Manage and support the internal audit and vendor audit program. Ensure the appropriate data is prepared and presented to review trend analysis on non-conformances, complaints, corrective & preventive actions, and audit data to focus efforts for process improvement. Organise and support a training program to ensure Quality System compliance. Complete Performance reviews with Quality team members, set and measure goals. Create and maintain training plans within the Quality group. Support the introduction of new products. Responsible for the validation programme. Health and Safety, support and maintenance of MSDS's. Qualifications. Educated to a minimum of degree level in a Science function. A minimum of 5- 7 year's experience working in a regulated medical device environment with a minimum of 3 years in a leadership role. Thorough knowledge of ISO13485, 21CFR820, IVDD 98/79/EC. Qualified ISO13485 lead auditor. Knowledge of international regulatory requirements relevant to IVD medical devices. 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

Date Added

339 days ago