Regulatory Affairs Specialist Role
We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and managing the entire lifecycle of medical devices.
Main Responsibilities:
* Manage all regulatory activities including product certification and compliance, and support the ongoing maintenance, audit, and continuous improvement of the Quality Management System.
* 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.
* Complaints handling 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.
Key Skills and Qualifications:
1. A third-level degree and significant experience in medical devices.
2. A post-graduate qualification in Quality Assurance along with experience of active medical devices would be an advantage.
3. Significant regulatory affairs experience, including experience of international regulatory processes.
4. In-depth knowledge of product certification testing requirements for active Medical Devices.
5. In-depth knowledge of maintaining a certified Quality Management System.
6. Knowledge and application of Quality tools and Methodologies, including Lean Six Sigma, TQM, etc.
7. Experience of EN/MDD/MDR, ISO13485, and FDA requirements.
8. Trained QMS Internal Auditor.
9. Strong attention to detail.
10. Excellent verbal and written communication skills.
11. Results-oriented and a self-starter with the ability to work on own initiative.
12. Knowledge of and commitment to continuous improvement and problem-solving.
13. Promote best practice and knowledge of the QSR and ISO/MDD standards.
14. Advanced Microsoft Office and reporting tool skills.
15. Strong project management skills.