Senior Regulatory Affairs Specialist
We are seeking a highly experienced Senior Regulatory Affairs Specialist to join our client, a leading medical device organization.
The successful candidate will be responsible for managing all regulatory activities, including product certification and compliance, as well as supporting the maintenance, audit, and continuous improvement of key elements of the Quality Management System.
Key Responsibilities:
* Manage the regulatory and vigilance process, ensuring timely and compliant submissions to relevant authorities.
* Prepare regulatory submissions for required markets, coordinating input from stakeholders and tracking product clearances to completion.
* Maintain technical files for cleared products, ensuring accuracy and completeness.
* Support the Senior Quality & Regulatory Manager in managing product certification testing and risk management processes.
* Handle complaints and reporting for medical devices, filing with competent authorities as required.
* Stay up-to-date with evolving regulatory requirements, including REACH, ROHS2, and other relevant standards.
* Maintain environmental registrations for all markets.
* Assist with labelling and packaging updates from a regulatory and clinical claims perspective.
* Lead internal audits and CE technical file audits for the company, ensuring adherence to QMS standards.
Requirements:
* A third-level degree and significant experience in medical devices.
* A post-graduate qualification in Quality Assurance is advantageous, particularly with active medical devices experience.
* Substantial regulatory affairs experience, including international processes and knowledge of product certification testing requirements.
* In-depth understanding of maintaining a certified Quality Management System, including Lean Six Sigma and TQM methodologies.
* Familiarity with EN/MDD/MDR, ISO13485, and FDA regulations.
* Trained QMS Internal Auditor with strong attention to detail and excellent communication skills.
* Results-driven and self-motivated, with ability to work independently.
* Dedication to continuous improvement and problem-solving, promoting best practice and knowledge of QSR and ISO/MDD standards.