QUALITY & REGULATORY MANAGER

Our client an indigenous Irish medical device company who has recently undergone significant investment are currently seeking a Quality and Regulatory Manager to join their team. Reporting to executive leadership the Quality and Regulatory Manager will have a proven ability to lead the quality assurance agenda across the company, possess knowledge of regulatory processes for EU and FDA product clearance, demonstrate excellent people and team management skills and experience of quality management in the context of R&D and design control. This is an exciting opportunity to join a company with huge growth plans


Role/Responsibilities

• To lead the company wide quality assurance agenda, ensuring that we meet customer requirements for products and services as well as regulatory compliance in target markets
• Ensure the effective functioning of continuous quality improvement based on performance measurement
• Ensure there is adequate control of design activity to ensure product quality
• Lead and manage all areas of Risk management as to relates to design control in accordance with ISO14971
• Responsible for the ongoing maintenance, audit and continuous improvement of the Quality Management System, to ensure compliance to relevant standards for Europe, UK, North America and Asia Pacific.
• Responsible for regulatory clearance and regulatory maintenance for the Company’s products in target markets
• Responsible for the implementation of the Home healthcare and electrical safety standards
• Management of the QA team
• Proactive management of the processes to ensure product and service quality
• Act as Management Representative for the Quality Management System
• Manage the maintenance of the Quality System to ISO13485, and FDA requirements
• Responsible for FDA facility inspections, notified body audits and other audits and inspections as required.
• Establish infrastructure to assure quality and work with relevant teams to ensure performance improvement.
• Ensure the effective functioning of design controls to ensure product quality.
• Represent the quality department in all NPI/NPD activities to ensure that all new products are compliant to appropriate international quality and regulatory requirements.
• Complaints handling for medical reporting and filing to the appropriate competent authorities.
• Regularly review and manage change control process to ensure it remains effective and efficient.
• Ensure products are cleared to the appropriate markets as per Regulatory plan
• Manage Regulatory Affairs support to internal and external customers.
• Ensure company is kept informed of and give direction on changing regulatory and compliance requirements e.g. REACH, ROHS2, etc.
• Manage the Quality team to ensure the proactive delivery of departmental objectives and empower the team to actively support and assist other departments in complying with quality requirements.
• Data collection and analysis for monthly meetings and management review

• University Degree or a Post Graduate qualification, preferably in Quality Assurance
• 8+ years of experience inMedical Devices or other similar regulated industry
• Significant regulatory affairs experience including experience of international regulatory processes
• Knowledge of product certification testing requirements for Medical Devices
• In depth knowledge of maintaining a certified Quality Management System
• Knowledge and application of Quality tools and Methodologies including lean six sigma, TQM etc.
• Previous experience of the impact of regulatory control on commercial products
• Trained QMS Internal Auditor
• Awareness of quality assurance processes
• High level of attention to detail
• Proven leadership skills
• Excellent verbal and written communication skills
• Results orientated and a self-starter with the ability to work on own initiative
• Knowledge of and commitment to continuous improvement and problem solving
• Promote best practice and knowledge of the QSR and ISO standards
• Advanced Microsoft Office and reporting tool skills
• Strong project management skills