Senior Quality & Regulatory Engineer - ISO ***** & Data Compliance
Location:
Hybrid - Belfast & Remote
Contract:
1-Year Fixed Term
Salary:
***********
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 *****
and
GDPR
.
Key Responsibilities:
Lead the implementation and ongoing management of
ISO ***** 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 *****
.
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 ****, ISO *****, EN *****, ISO *****).
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.
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