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