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 Company’s 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
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