Senior Regulatory Affairs Specialist
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our medical device organisation.
Key Responsibilities:
* Manage regulatory and vigilance processes, ensuring compliance with international regulations.
* Prepare and coordinate regulatory submissions for global markets, including tracking product clearances and certification.
* Maintain technical files for cleared products and support the ongoing maintenance of the Quality Management System.
* Support the Senior Quality & Regulatory Manager in managing product certification testing and risk management processes.
* Handle complaints and report them to relevant authorities while maintaining confidentiality.
* Stay up-to-date with changing regulatory requirements, including REACH, ROHS2, and FDA guidelines.
* Maintain environmental registrations and support labelling and packaging updates from a regulatory perspective.
Requirements:
* Third-level degree and significant experience in medical devices.
* Post-graduate qualification in Quality Assurance is an advantage, particularly if accompanied by experience in active medical devices.
* Substantial regulatory affairs experience, including knowledge of international regulatory processes.
* In-depth understanding of product certification testing requirements and certified Quality Management Systems.
* Knowledge of quality tools, methodologies, and standards, such as EN/MDD/MDR, ISO13485, and FDA requirements.
* Trained QMS Internal Auditor with strong attention to detail and excellent communication skills.
Skills:
* Excellent verbal and written communication skills.
* Results-oriented and self-motivated, with the ability to work independently.
* Knowledge of and commitment to continuous improvement and problem-solving.
* Promotion of best practices and knowledge of QSR and ISO/MDD standards.
* Advanced Microsoft Office and reporting tool skills.