Medical Device Regulatory Affairs Role
The company seeks a skilled Regulatory Affairs Specialist to oversee all regulatory activities, ensuring compliance with relevant regulations and standards. This role requires expertise in product certification, vigilance, and Quality Management Systems (QMS).
* Responsibilities:
* Manage the regulatory process for medical devices.
* Prepare submissions for markets, coordinating input from stakeholders and tracking clearances to completion.
* Maintain technical files for cleared products.
* Support Senior Quality & Regulatory Manager in managing product certification testing.
* Support Risk Management process for existing and new products.
* Handle complaints for medical reporting and filing.
* Stay up-to-date with changing regulatory requirements.
* Maintain environmental registrations for markets.
* Support labelling and packaging updates.
* Complete internal audits as required and lead CE technical file audits.
* Support Quality team in maintaining QMS.
Requirements:
* A third-level degree and significant experience in medical devices.
* Post-graduate qualification in Quality Assurance is advantageous.
* Significant regulatory affairs experience, including international processes.
* In-depth knowledge of product certification testing requirements.
* Knowledge of certified QMS and quality tools/methodologies.
* Experience with EN/MDD/MDR, ISO13485, and FDA requirements.
* Strong attention to detail and excellent communication skills.
* Promote best practice and knowledge of QSR and ISO/MDD standards.
* Advanced Microsoft Office and reporting tool skills.
We offer:
A challenging and rewarding role in a dynamic industry.
Contact us: