Our client an indigenous Irish medical device company who has recently undergone significant investment are currently seeking a Quality and Regulatory Manager to join their team.
Quality and Regulatory Manager responsible for setting quality objectives, developing and implementing quality control procedures, managing a team of analysts, and ensuring regulatory compliance.
Role/Responsibilities: Overseeing and coordinating quality control activities.
Monitoring process performance.
Ensuring compliance with regulatory requirements.
Managing a team of quality control analysts.
Developing and implementing quality management systems.
Conducting audits and inspections.
Reviewing and approving standard operating procedures.
Ensure the effective functioning of continuous quality improvement based on performance measurement Responsible for regulatory clearance and regulatory maintenance for the Companys products in target markets Management of the QA team Ensure products are cleared to the appropriate markets as per Regulatory plan Data collection and analysis for monthly meetings and management review Skills: Effective communication skills Attention to detail Critical thinking Problem-solving abilities Strong leadership skills Deep understanding of quality systems and regulations are crucial for success in this role.
Our ideal candidate is: 3+ years of experience in Medical Devices or other similar regulated industry Significant regulatory affairs experience including experience of international regulatory processes Knowledge of product certification testing requirements for Medical Devices In depth knowledge of maintaining a certified Quality Management System Proficient in computer technology and systems with an in-depth knowledge of market trends and conditions.
Benefits: Competitive Salary Flexible working hours Training provided Skills: Quality Manager Pharmaceutical