Quality & Regulatory Manager
We are seeking a Quality and Regulatory Manager to join our client, an indigenous Irish medical device company that has recently undergone significant investment. Reporting to executive leadership, the Quality and Regulatory Manager will lead the quality assurance agenda across the company, possess knowledge of regulatory processes for EU and FDA product clearance, demonstrate excellent people and team management skills, and experience of quality management in the context of R&D and design control.
Key Responsibilities:
* Lead the company-wide quality assurance agenda, ensuring customer requirements for products and services as well as regulatory compliance in target markets.
* Evaluate the effectiveness of continuous quality improvement based on performance measurement.
* Ensure adequate control of design activity to ensure product quality.
* Manage risk related to design control in accordance with ISO14971.
* Maintain, audit, and continuously improve the Quality Management System to ensure compliance to relevant standards for Europe, UK, North America, and Asia Pacific.
* Secure regulatory clearance and maintenance for the Company's products in target markets.
* Implement Home healthcare and electrical safety standards.
* Oversee the QA team.
* 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 ISO13485 and FDA requirements.
* Represent the quality department in all NPI/NPD activities to ensure new products comply with international quality and regulatory requirements.
* Handle complaints for medical reporting and filing to competent authorities.
* Regularly review and manage change control process to ensure efficiency.
* Ensure products are cleared to appropriate markets as per Regulatory plan.
* Provide Regulatory Affairs support to internal and external customers.
* Keep the company informed of changing regulatory and compliance requirements.
Requirements:
* University Degree or Post Graduate qualification in Quality Assurance.
* 8+ years of experience in Medical Devices or similar regulated industry.
* Significant regulatory affairs experience including international regulatory processes.
* Knowledge of product certification testing requirements for Medical Devices.
* In-depth knowledge of maintaining a certified Quality Management System.
* Familiarity with Quality tools and Methodologies including lean six sigma, TQM, etc.
* Previous experience of the impact of regulatory control on commercial products.
* Trained QMS Internal Auditor.
* Awareness of quality assurance processes.
* High level of attention to detail.
* Proven leadership skills.
* Excellent verbal and written communication skills.
* Results-oriented and self-starter with 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 standards.
* Advanced Microsoft Office and reporting tool skills.
* Strong project management skills.