Our client, a growing medical device organisation, seeks a Senior Regulatory Affairs Specialist.
Role and Responsibilities
* Manage the regulatory and vigilance process.
* Prepare regulatory submissions for required markets, coordinating input from other stakeholders, tracking and supporting product clearances and certification to completion.
* Maintain technical files for all cleared products.
* Support the Senior Quality & Regulatory Manager in managing any required product certification testing.
* Support the Senior Quality & Regulatory Manager in managing the Risk Management process for all existing and new products.
* Handle complaints for medical reporting and filing to the appropriate competent authorities.
* Keep up to date with changing regulatory and compliance requirements.
* Maintain environmental registrations for all markets.
* Support labelling and packaging updates and creations from a regulatory and clinical claims perspective.
* Complete internal audits as required and lead CE technical file audits for the company.
* Support the Quality team in maintaining the QMS.
Requirements
* You will have a third level degree and significant experience in medical devices.
* A post-graduate qualification in Quality Assurance along with experience of active medical devices would be an advantage.
* SIGNIFICANT REGULATORY AFFAIRS EXPERIENCE INCLUDING EXPERIENCE OF INTERNATIONAL REGULATORY PROCESSES.
* In-depth knowledge of product certification testing requirements for active Medical Devices.
* In-depth knowledge of maintaining a certified Quality Management System.
* Knowledge and application of Quality tools and methodologies.
* Experience of EN/MDD/MDR, ISO13485, and FDA requirements.
* Trained QMS Internal Auditor.
* Strong attention to detail.
* Excellent verbal and written communication skills.
* Results-oriented and a self-starter with the ability to work on own initiative.
* Knowledge of and commitment to continuous improvement and problem solving.
* Promote best practice and knowledge of the QSR and ISO/MDD standards.
* Advanced Microsoft Office and reporting tool skills.
* Strong project management skills.