Ref No: AM17559
Galway, Co. Galway, Ireland
Senior Regulatory Affairs Specialist - Galway.
In this role you will be responsible for all regulatory activities including product certification and compliance, and for supporting the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System
Core aspects of the role include:
• Manage the regulatory and vigilance process.
• Prepare regulatory submissions for required markets, co-ordinating input from other stakeholders, tracking and supporting product clearances and certification to completion.
• Maintain technical files for all cleared products.
• Support the Senior Quality & Regulatory Manager in managing any required product certification testing.
• Support the Senior Quality & Regulatory Manager in managing the Risk Management process for all existing and new products.
• Complaints handling for medical reporting and filing to the appropriate competent authorities.
• Keep up to date with changing regulatory and compliance requirements e.g. REACH, ROHS2 etc.
• Maintain environmental registrations for all markets.
• Support labelling and packaging updates and creations from a regulatory and clinical claims perspective.
• Complete internal audits as required and lead CE technical file audits for the company.
• Support the Quality team in maintaining the QMS
Interested applicants should have a third level degree and a significant amount of experience in medical devices. A post-graduate qualification in Quality Assurance along with experience of active medical devices would be an advantage.
• Significant regulatory affairs experience, including experience of international regulatory processes.
• In-depth knowledge of product certification testing requirements, ideally for active 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.
• Experience of EN/MDD/MDR, ISO13485 and FDA requirements.
• Strong attention to detail.
• Excellent verbal and written communication skills.
• Strong project management skills.