Regulatory Affairs & Quality Manager
Our client a cardiovascular medical device start-up looking to hire a Quality and Regulatory Affairs manager. The successful candidate will be responsible for implementing and maintaining the organisation's Quality System. They will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the relevant Regulatory and Notified Bodies. They will also be required to help maintain the Design History File of Class III implant. This position offers the opportunity to join the management team in an exciting early stage company
Role and responsibilities:
• Develop, manage and optimise the Quality System to assure compliance with EU, US and international regulations, ISO standards and directives including the Medical Device Directive
• Continuous improvement of the QMS to meet the requirements of all stakeholders
• Manage supplier evaluations and audits
• Act as the primary point of contact with Regulatory authorities and the Notified Body to ensure the company’s activities are aligned to their requirements
• Manage all quality related activities for device manufacturing ensuring effective and efficient process controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
• Support product verification and validation, including risk management, bio-compatibility testing (ISO 10993), microbiological (disinfection) validation and clinical evaluation
• Develops and manage a high-performance quality engineering team. Create a strong team working environment with focus on compliance, product quality, and risk mitigation.
• Lead the activities of Quality Team
• Manage Quality System audit processes
• Provide training to company employees in relevant areas of the quality system
• Bachelor degree in science, engineering or related field
• Proven track record in a similar role with a minimum of 8 years in medical device quality systems or equivalent
• Extensive knowledge of quality management systems, design controls per ISO 13485 and current International and European regulations/standards with respect to medical devices.
• In depth knowledge of the EU Medical Device Directive and MEDDEV guidance documents
• Experience in design, verification and process validation processes
• Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems
• Prior experience in class III medical products highly preferred
• Prior experience in a medical device start up preferred.
• Good leadership and project management skills with the ability and willingness to effectively build and manage a small team. Experience in people management and development.
• Excellent verbal and written communication skills
Availability to travel is required
James Cassidy | Tel: +353 (0) 1 5079250