Regulatory Affairs Specialist Opportunity
The Regulatory Affairs Specialist will play a crucial role in ensuring compliance with regulatory requirements for our products.
* Manage the regulatory process, including product certification and vigilance.
* Prepare and submit regulatory documents for required markets, coordinating input from other stakeholders.
* Maintain technical files for cleared products, ensuring they meet regulatory standards.
* Support the Senior Quality Manager in managing product certification testing and the Risk Management process.
* Handle medical device complaints and report to competent authorities as necessary.
* Stay up-to-date with changing regulatory requirements, such as REACH and ROHS2.
* Maintain environmental registrations for all markets.
* Support labelling and packaging updates from a regulatory perspective.
Key Requirements:
* You will hold a third-level degree and significant experience in medical devices.
* A post-graduate qualification in Quality Assurance would be advantageous, especially with active medical device experience.
* Significant regulatory affairs experience is essential, including international regulatory processes.
* In-depth knowledge of product certification testing requirements for active Medical Devices.
* Maintaining a certified Quality Management System is critical.
* Familiarity with Quality tools and Methodologies, including Lean Six Sigma.
* Experience with EN/MDD/MDR, ISO 13485, and FDA requirements is necessary.
* Strong attention to detail, excellent communication skills, and results-oriented attitude are required.