Ref No: AM17494
Galway, Co. Galway, Ireland
Senior Quality & Regulatory Manager - Galway.
In this role you will lead the company-wide Quality Management system ensuring it meets design specifications and standards for products and services. The role also has responsibility for regulatory clearance and compliance in target and existing markets, as well as providing technical support and guidance for new product introductions, and labelling and marketing claims.
• Proactive management of the processes to ensure product and service quality.
• Act as Management Representative for the Quality Management System and have authority for same
• Ensuring that processes needed for the quality management system are documented.
• Reporting to top management on the effectiveness of the quality management system and any need for improvement.
• Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organisation.
• Take responsibility for the ongoing maintenance, audit, and continuous improvement of the Quality Management System, based on performance measurement, to ensure compliance to EN/MDD/MDR, ISO13485 and FDA requirements.
• Ensure there is a robust quality system in place around web customers and app users e.g., web complaints, doc control etc.
• 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.
• Generate and maintain instructions for use and regulatory labelling for all products.
• Ensure that software and firmware is being developed in accordance with IEC 62304.
• Regularly review and manage DOC control process to ensure it remains effective and efficient.
• Ensure the development and maintenance of the risk management plan in accordance with ISO 14971
• Ensure products are cleared to the appropriate markets as per Regulatory plan and manage regulatory maintenance in existing territories.
• Ensure company is kept informed of and given direction on changing regulatory and compliance requirements e.g., REACH ROHS2 etc
• Support the commercial team with respect to compliance with local regulatory laws and environmental regulations in market as well as advertising/clinical claims.
• Responsible for Post-Marketing Surveillance for the company and reporting to appropriate regulatory bodies as required.
• Complaints handling for medical reporting and filing to the appropriate competent authorities.
• Work with commercial managers to manage and maintain relationships with industry Key Opinion Leaders.
• Effectively lead and manage the QA/RA team, identifying and addressing any training and development needs.
Interested applicants should have:
A relevant third level degree and/or a post-graduate qualification in Quality Assurance. You will have at least eight to ten years’ experience in medical devices (active medical devices an advantage), successfully managing a quality and regulatory team.
• Significant regulatory affairs experience including experience of international regulatory processes including FDA, EU, and UK for Medical Devices.
• In-depth knowledge of maintaining a certified Quality Management System.
• Knowledge of product certification testing requirements for Medical Devices.
• Knowledge and application of Quality tools and methodologies including lean six sigma etc.
• Previous experience of the impact of regulatory control on commercial products and their claims in advertising.
• Knowledge of IEC 62304 (medical device software lifecycle process).
• Knowledge of the regulatory requirements for active medical devices.
• Trained QMS Internal Auditor.
• Awareness of online quality assurance processes.
• Promote implementation experience of the QSR and ISO/MDD/MDR standards.
• 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.
• Advanced Microsoft Office and reporting tool skills.
• Strong project management skills.