Regulatory Affairs Specialist
Job Description:
The Regulatory Affairs Specialist will be responsible for managing the regulatory and vigilance process, preparing regulatory submissions, maintaining technical files, and supporting quality and regulatory management.
* Manage the regulatory and vigilance process to ensure compliance with EU, UK, and FDA regulations.
* Prepare regulatory submissions for required markets, coordinating input from other stakeholders and tracking product clearances and certification.
* Maintain technical files for all cleared products, including documentation of design controls, risk management, and clinical evaluation.
* Support senior quality and regulatory managers in managing product certification testing and risk management processes.
* Handle complaints and medical reporting, filing with competent authorities as needed.
* Stay up-to-date with changing regulatory requirements, such as REACH and ROHS2.
* Maintain environmental registrations for all markets.
* Support labelling and packaging updates and creations from a regulatory and clinical claims perspective.
* Complete internal audits and lead CE technical file audits.
* Support quality teams in maintaining quality management systems.
* Expert knowledge of regulatory processes for EU, UK, and FDA product clearance.
* Working experience of regulatory processes for ROW markets and certified quality management systems.
Requirements:
* Third-level degree and significant experience in medical devices.
* Post-graduate qualification in quality assurance, along with experience in active medical devices, is an advantage.
* Significant regulatory affairs experience, including international regulatory processes.
* In-depth knowledge of product certification testing requirements for active medical devices.
* Knowledge and application of quality tools and methodologies, including lean six sigma and TQM.
* Experience of EN/MDD/MDR, ISO13485, and FDA requirements.
* Trained QMS internal auditor.
* Strong attention to detail and excellent verbal and written communication skills.
* Results-oriented and self-starter with ability to work independently.
* Knowledge of continuous improvement and problem-solving.
* Promote best practice and knowledge of QSR and ISO/MDD standards.
* Advanced Microsoft Office and reporting tool skills.
* Strong project management skills.