Quality & Regulatory Manager
We are seeking a Quality and Regulatory Manager to join our indigenous Irish medical device company, which has recently undergone significant investment.
Responsibilities:
* Lead the company-wide quality assurance agenda, ensuring compliance with customer requirements and regulatory standards.
* Implement continuous quality improvement based on performance measurement.
* Manage risk management processes related to design control in accordance with ISO 14971.
Key Responsibilities:
* Maintenance of the Quality Management System (QMS) to ensure compliance with relevant international standards.
* Regulatory clearance and maintenance for products in target markets.
* Implementation of home healthcare and electrical safety standards.
Requirements:
* University degree or postgraduate qualification in Quality Assurance.
* 8+ years of experience in Medical Devices or a similar regulated industry.
* Significant regulatory affairs experience, including knowledge of international regulatory processes.
Skills:
* Leadership skills.
* Excellent verbal and written communication skills.
* Results-oriented and self-starter with ability to work independently.
We are looking for a highly motivated individual with a strong background in quality assurance and regulatory affairs. If you are passionate about delivering high-quality products and services, please submit your application.