Job Title: Quality and Regulatory Manager
We are seeking a seasoned Quality and Regulatory Manager to lead our quality assurance agenda, ensuring compliance with regulatory requirements in target markets.
Job Description:
The successful candidate will have a proven track record of leading quality assurance initiatives, managing risk, and ensuring the effective functioning of design controls. They will also be responsible for maintaining a certified Quality Management System, managing regulatory clearance and maintenance, and representing the quality department in NPI/NPD activities.
Key Responsibilities:
* Lead the company-wide quality assurance agenda, ensuring compliance with customer requirements and regulatory standards.
* Manage the implementation of continuous quality improvement programs based on performance measurement.
* Ensure adequate control of design activity to ensure product quality.
* Lead and manage all areas of risk management related to design control in accordance with ISO14971.
* Maintain the ongoing maintenance, audit, and continuous improvement of the Quality Management System.
* Responsible for regulatory clearance and maintenance for the Company's products in target markets.
Requirements:
* University Degree or Post Graduate qualification in Quality Assurance or related field.
* At least 8 years of experience in Medical Devices or similar regulated industry.
* Significant regulatory affairs experience, including international regulatory processes.
* In-depth knowledge of maintaining a certified Quality Management System.
Benefits:
This is an exciting opportunity to join a company with huge growth plans and contribute to the development of a world-class Quality Management System.