Senior Quality & Regulatory Engineer
Hybrid - Belfast, NI | Permanent, Full-Time | Competitive Salary
Ocho People are proud to be partnering with our client, an innovative AI precision medicine company helping Biotech and Pharma organisations unlock the power of their data to accelerate drug and diagnostics development.
We're seeking a Senior Quality & Regulatory Engineer to lead ISO, data protection, and compliance initiatives across the business. This is a fantastic opportunity to join a fast-growing company making a real impact in global healthcare innovation.
Key Responsibilities
Lead quality projects and implement ISO 27001 requirements.
Manage and maintain GDPR and Data Protection Act compliance.
Maintain and improve the Quality Management System (QMS).
Conduct internal audits and identify regulatory gaps.
Support compliance planning and supervise one junior team member.
About You
Proven experience in a regulated software or medical environment.
Strong knowledge of ISO 27001 and GDPR.
Skilled in internal auditing and quality system management.
Detail-focused, adaptable, and proactive with great communication skills.
Nice to Have
Experience with ISO 9001, 13485, or similar QMS standards.
Awareness of AI or medical device regulations.
Familiarity with AWS cloud and US data protection laws.
Benefits
Competitive salary and pension.
Hybrid and flexible working (Flexi Fridays / No-Meeting Fridays).
25 days annual leave + 10 public holidays.
Health plan and enhanced family leave.
Ongoing training and development.
Join a mission-driven team using AI and data to drive real breakthroughs in healthcare. Apply now to be part of the journey.