Our organisation is seeking a Senior Regulatory Affairs Specialist.
The ideal candidate will be responsible for all regulatory activities, including product certification and compliance, as well as supporting the ongoing maintenance, audit, and continuous improvement of specific elements of our Quality Management System.
1. Manage the regulatory and vigilance process.
2. Prepare regulatory submissions for required markets, coordinating input from other stakeholders, tracking, and supporting product clearances and certification to completion.
3. Maintain technical files for all cleared products.
4. Support our Quality team in managing any required product certification testing.
5. Support our Quality team in managing the Risk Management process for all existing and new products.
6. Handle complaints related to medical reporting and filing with the appropriate authorities.
7. Stay up-to-date with changing regulatory and compliance requirements.
8. Maintain environmental registrations for all markets.
9. Support labelling and packaging updates and creations from a regulatory and clinical claims perspective.
10. Complete internal audits as required and lead CE technical file audits.
11. Support our Quality team in maintaining the QMS.
12. Expert knowledge of regulatory processes for EU, UK, and FDA product clearance.
13. Working experience of regulatory processes for ROW markets.
14. Working experience of a certified Quality Management System.
Requirements:
* Third-level degree and significant experience in medical devices.
* Post-graduate qualification in Quality Assurance, along with experience in active medical devices, would be an advantage.
* Significant regulatory affairs experience, including 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 self-starter with the ability to work independently.
* 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.