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Quality and Regulatory Manager
Job summary
A leading recruitment agency is seeking a Quality and Regulatory Manager in Belfast. This role involves leading quality initiatives and ensuring compliance with ISO standards and GDPR. The ideal candidate will have experience in regulated software environments and a detail-oriented approach. This position offers flexible working, competitive salary, and a supportive team.
Benefits
Qualifications
- Experience in a regulated software environment such as medtech or pharma.
- Knowledge of ISO 27001 and GDPR compliance.
- Ability to manage quality initiatives effectively.
Responsibilities
- Lead quality initiatives aligned with ISO 27001 and the EU AI Act.
- Maintain compliance with EU/UK GDPR and manage Data Protection processes.
- Manage and audit ISO 13485-certified Quality Management System.
Skills
MCS Group is proud to be recruiting a Quality and Regulatory Manager to join our innovative partner within the life science/health tech space. This is a role that offers a unique chance to work at the intersection of AI, healthcare, and regulatory compliance.
Key Responsibilities:
- Lead quality initiatives aligned with ISO 27001, the EU AI Act & Cyber Resilience Act
- Maintain compliance with EU/UK GDPR and support Data Protection processes
- Manage and audit ISO 13485-certified QMS
- Identify regulatory changes and drive internal compliance
Essential:
- Regulated software environment experience (e.g. medtech, pharma)
- ISO 27001 & GDPR knowledge
- Detail-oriented and collaborative mindset
Nice to Have (but not essential):
- ISO 13485, EN 62304, or ISO 14971 experience
- US data protection knowledge
- Familiarity with AI/Cyber regulations or AWS
What you will get:
- Flexible Working
- Competitive Salary
- Supportive Team
To speak in absolute confidence about this opportunity please send an up to date CV via the link provided or contact Kathy Donaghey Senior Specialist Consultant at MCS Group 028 96 93 5521
Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs
Not all agencies are the same…MCS Group are passionate about providing a first-class service to all our customers and have an independent review rating of 4.9 stars on Google
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.
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