Our client a growing medical device organisation currently seeks a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist 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


Role/Responsibilities

• Manage the regulatory and vigilance process.
• Prepare regulatory submissions for required markets coordinating 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
• Expert Knowledge of regulatory processes for EU, UK and FDA product clearance.
• Working experience of regulatory processes for ROW markets.
• Working experience of a certified Quality Management System.

• You will 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 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.
• Trained QMS Internal Auditor.
• Strong attention to detail.
• 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/MDD standards.
• Advanced Microsoft Office and reporting tool skills.
• Strong project management skills.