Ref No: AM17353
Co. Dublin, Ireland
QA/RA Director - South Dublin.
In this role, you will be responsible for leading the RA/QA team within the organisation, over 2 sites, to ensure compliance to international quality and regulatory requirements.
• Development and implementation of a strong and effective RA/QA strategy.
• Product submissions/approvals, license renewals, periodic updates and product company registrations to regulatory agencies (CE, US, China, etc.)
• Fulfil role of Management Representative of the Company Management System, and act as the main point of contact with QMS certification/notified bodies, regulator and Competent Authorities (in support of vigilance reporting as required)
• Documented QMS.
• Lead team during external audit as well as during authorities or customer inspection.
• Risk Management, Deviation & CAPA Management, Complaint Management, Post Market Surveillance and Quality auditing.
• Ensure that evolving international standards and regulations of interest are identified and anticipated.
• Will be the first contact person for all QA/RA matters.
• Collaborate with other members of management to develop new product and engineering designs and manufacturing and training methods.
• Achieve financial objectives by preparing the QA/RA budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
• Contribute to team effort by accomplishing related results as needed.
• Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
Interested applicants should have:
• Advanced science degree with circa 7 to 10 years’ experience.
• Strong RA and QA background for medical devices or pharmaceuticals
• Knowledge of global regulatory standards required (EU, China, US) and international registration processes.
• Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices.
• Excel, PowerPoint, Word, Excel proficiency
• Experience with responding to regulatory inquiries and building company compliance programs.
• Ability to develop RAQA staff by recruiting, selecting, orienting, coaching and training employees
• Comfortable with technical data, and be able to effectively present and respond to questions on global requirements and practices.
• Development of the members in the team to effectively execute the RA/QA activities.
• Knowledge of safety requirements and legal standards.