23 Sep 2025 BBBH60296 Senior Quality & Regulatory Engineer £40000.00 - £50000.00 per annum + Hy ...

Senior Quality & Regulatory Engineer - ISO 27001 & Data Compliance

Location: Hybrid - Belfast & Remote
Contract: 1-Year Fixed Term
Salary: 0
Reports to: Head of Operations

The Company

This is a cutting-edge AI-driven precision medicine organisation that's helping global Biotech and Pharma companies unlock the full potential of their data. Their platform is used to reduce cost, time, and risk across early discovery and clinical trials, while ensuring data is managed securely, compliantly, and effectively within a trusted research environment.

The business has grown rapidly over the past two years-expanding internationally, scaling the team to 35+, and winning multiple industry awards. They now have an exciting opportunity for a Senior Quality & Regulatory Engineer to join their team and lead on information security and data protection compliance.

The Role

This is a unique position at the intersection of quality, regulatory compliance, and data governance. The successful candidate will play a key role in building and maintaining a robust compliance culture across the organisation, with a particular focus on ISO 27001 and GDPR.

Key Responsibilities:

• Lead the implementation and ongoing management of ISO 27001 certification across the business, collaborating with subject matter experts.

• Manage compliance with EU & UK GDPR and the UK Data Protection Act, supporting the Data Protection Officer in customer-facing requests.

• Oversee the Quality Management System (QMS), ensuring it remains effective and audit-ready.

• Perform internal audits and gap assessments, developing compliance plans for emerging regulations.

• Supervise and support an Officer-level team member.

The Person

We're looking for someone detail-oriented, pragmatic, and passionate about data compliance and quality. You'll thrive in a dynamic, fast-growing business where adaptability and collaboration are key.

Essential Experience:

• Strong working knowledge and hands-on experience with ISO 27001.

• Background in software development quality within a regulated sector (e.g. medical devices, pharma, biotech, or similar).

• Direct experience with EU & UK GDPR compliance.

• Proven internal auditing skills.

Desirable (but not essential):

• Experience with ISO-certified QMS (ISO 9001, ISO 13485, EN 62304, ISO 14971).

• Knowledge of US data protection laws, AI Act, or Cyber Resilience Act.

• Familiarity with cloud infrastructure (AWS preferred).

• Medical device regulation knowledge (EU IVDR, EU MDR, UK MDR).

• Lead Auditor certification.

Benefits & Culture

• Competitive salary & pension contribution.

• Hybrid & flexible working.

• 25 days annual leave + 10 public holidays.

• Private health cover.

• Enhanced parental leave.

• Training budget & strong development culture.

• £300 home office equipment allowance.

To speak in absolute confidence about this opportunity please send an up-to-date CV via the link provided or contact Senior Recruitment Consultant Stuart Kennedy at MCS Group on or .

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.