Job Description

QA/RA Director

Ref No: AM17353

Co. Dublin, Ireland

Competitive salary

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.

Core responsibilities:
• 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.