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Job Description
Quality and Regulatory Manager sought to lead quality assurance agenda and ensure regulatory compliance in target markets.
Our client, an indigenous Irish medical device company, is seeking a Quality and Regulatory Manager to join their team. Reporting to executive leadership, the successful candidate will have a proven ability to lead the quality assurance agenda across the company, possess knowledge of regulatory processes for EU and FDA product clearance, and demonstrate excellent people and team management skills.
The Quality and Regulatory Manager will be responsible for:
- Leading the company-wide quality assurance agenda, ensuring compliance with customer requirements and regulatory standards
- Ensuring the effective functioning of continuous quality improvement based on performance measurement
- Managing risk management and design control in accordance with ISO14971
- Maintaining and improving the Quality Management System to ensure compliance with relevant standards
- Managing regulatory clearance and maintenance for the company's products in target markets
- Implementing home healthcare and electrical safety standards
- Managing the QA team and ensuring proactive management of processes to ensure product and service quality
- Representing the quality department in NPI/NPD activities to ensure compliance with international quality and regulatory requirements
- Handling complaints and reporting to competent authorities
- Reviewing and managing change control processes
- Ensuring products are cleared to target markets and managing regulatory affairs support
- Managing the Quality team to deliver departmental objectives and empower the team to support other departments
- Data collection and analysis for management review
The ideal candidate will have:
- University degree or postgraduate 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
- Knowledge and application of Quality tools and Methodologies
- 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 QSR and ISO standards
- Advanced Microsoft Office and reporting tool skills
- Strong project management skills