Quality & Regulatory Manager
Our client, an indigenous Irish medical device company that has recently undergone significant investment, is seeking a Quality and Regulatory Manager to lead their quality assurance agenda.
Reporting to executive leadership, the successful candidate will have a proven ability to:
* Lead the company-wide quality assurance agenda, ensuring compliance with customer requirements and regulatory standards.
* Develop and implement continuous quality improvement processes based on performance measurement.
* Manage design activity to ensure product quality and lead risk management in accordance with ISO 14971.
The ideal candidate will possess:
* Knowledge of regulatory processes for EU and FDA product clearance.
* Excellent people and team management skills.
* Experience of quality management in the context of R&D and design control.
Responsibilities:
Key Responsibilities
* Lead the quality assurance agenda, ensuring compliance with customer requirements and regulatory standards.
* Develop and implement continuous quality improvement processes based on performance measurement.
* Manage design activity to ensure product quality and lead risk management in accordance with ISO 14971.
* Maintain and improve the Quality Management System, ensuring compliance with relevant standards for Europe, UK, North America, and Asia Pacific.
* Obtain and maintain regulatory clearance and maintenance for products in target markets.
* Implement Home Healthcare and Electrical Safety Standards.
* Manage the QA team and proactively manage processes to ensure product and service quality.
* Act as Management Representative for the Quality Management System.
* Manage the maintenance of the Quality System to ISO 13485 and FDA requirements.
* Represent the quality department in all NPI/NPD activities, ensuring compliance with international quality and regulatory requirements.
* Handle complaints, reporting, and filing to competent authorities.
* Regularly review and manage change control processes to ensure effectiveness and efficiency.
* Ensure products are cleared to appropriate markets as per the Regulatory plan.
* Manage Regulatory Affairs support to internal and external customers.
* Inform and direct the company on changing regulatory and compliance requirements.
Requirements
1. University degree or postgraduate qualification in Quality Assurance.
2. 8+ years of experience in Medical Devices or similar regulated industries.
3. Significant regulatory affairs experience, including knowledge of international regulatory processes.
4. In-depth knowledge of maintaining a certified Quality Management System.
5. Knowledge and application of Quality tools and Methodologies, including Lean Six Sigma, TQM, etc.
6. Previous experience of the impact of regulatory control on commercial products.
7. Trained QMS Internal Auditor.
8. Awareness of quality assurance processes.
9. High level of attention to detail.
10. Proven leadership skills.
11. Excellent verbal and written communication skills.
12. Results-oriented and self-starter with the ability to work independently.
13. Knowledge of and commitment to continuous improvement and problem-solving.
14. Promote best practice and knowledge of QSR and ISO standards.
15. Advanced Microsoft Office and reporting tool skills.
16. Strong project management skills.