Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

Google Chrome
Internet Explorer
Mozilla Firefox

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Apply for this job






Salary Expectations:



Current Location:

Notice Period:

Write here your cover note:

If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to

Head of Quality & Regulatory Affairs

Reference:JC/HQ00001989 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Head of Quality & Regulatory Affairs

Our client a multinational healthcare company currently seeks Head of Quality and Regulatory Affairs. Reporting to General Manager with a dotted line to Corporate V.P. QA & RA the head of Quality and Regulatory will manage a team of 7 people and be responsible for management, development and improvement of current quality system as well as the completion of PMA’s. As well as being a key player in transfer of new products from development to manufacturing

Role / Responsibilities:
• Administer and maintain the Quality System
• Monitor the suitability and effectiveness of the Quality System and assure compliance with current US and international regulations and ISO standards.
• Continuous improvement of the system to meet the evolving expectations of customers, business partners and regulators
• Preparation for and completion of premarket approval applications (PMA) to the FDA for new products
• Define the Quality Assurance and Regulatory Affairs Budget Proposal (new SW, Inspection, Training, Translation, HC,…) and assure constant monitoring of it.
• Appropriately escalate Quality and Regulatory issues to the Corporate VP of QA/RA
• Manage and lead the activities of Quality Team
• Ensure the Quality System supports the corporate quality policy and quality objectives
• Keep abreast of changes in domestic and international Quality Systems regulations and guidelines, and advise Key staff of compliance/non compliance with current international regulations, policies and EC directives
• Manage Quality System audit processes
• Manage the communication with the regulatory authorities
• Advise Key staff of compliance/non compliance with current international regulations, policies and EC directives.
• Manage the Validation function
• Support the development and implementation of EHS projects, risk assessment, procedures and instructions and to oversight on the correct application, including self-audits in the area of responsibility (e.g. PPE)

• Science Degree or equivalent
• Qualification in Quality Assurance is essential.
• More than 8 years experience in a quality assurance role in the pharmaceutical, healthcare or medical device/IVD sector and in a FDA regulated environment is essential with no less than 3 years experience working in a Senior Management role
• Successful preparation for and completion of premarket approval applications (PMA) to the FDA.
• Successful preparation for and completion of an FDA Audit
• Intensive knowledge of quality management systems and current International and European regulations/standards with respect to medical devices.
• Successful implementation of a Quality IT System implementation is essential
• Knowledge of US and international medical device Quality System regulations and ISO standards
• Highly developed written and verbal communication skills
• Independent problem solving skills
• Understanding of immunoassay principles
• Proficient in data collection, analysis and presentation
• Experience and knowledge in design, verification and process validation techniques
• Experience and knowledge in designing, verifying, optimizing the processes within the organization to guarantee the compliance
• Experience with statistical techniques (DOE, Six Sigma)
• Sets and communicates the right priorities to the Quality Team
• Manages time consistently with a multi-tasking approach
• Manages with transparency
• Ability to work under pressure and meet tight deadlines
• Ability to make decisions quickly and effectively
• Self-motivator
• Flexibility

James Cassidy | Tel: +353 (0) 1 5079250