Regulatory Compliance Specialist

Regulatory Compliance Specialist

Biotechnology | Biobanking | Remote UK

We are seeking a Regulatory Compliance Specialist to support international biospecimen procurement and biobanking operations, ensuring ethical sourcing, regulatory compliance and robust quality standards across a global vendor network.

Key Responsibilities

• Monitor international regulations governing human biological materials, biobanking and cross border transport.
• Conduct remote vendor audits, compliance reviews and supplier qualification.
• Review vendor licences, accreditations, informed consent forms and IRB/IEC approvals.
• Assess regulatory and ethical risks associated with biospecimen sourcing.
• Develop, review and maintain SOPs, compliance checklists and quality documentation.
• Support eQMS/document control and CAPA tracking.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology or a related discipline.
• 5+ years’ experience in Regulatory Affairs, QA or Compliance within biotech, pharma, CRO or biobanking.
• Knowledge of GCP/GCLP, ISO 20387, GDPR/HIPAA and human sample ethics.
• Experience with vendor audits, informed consent documentation and SOP development.
• Familiarity with eQMS platforms; Cognidox experience is an advantage.
• Excellent written and spoken English, strong attention to detail and independent working skills.

What’s Offered

• Fully remote working.
• Competitive compensation.
• Professional development opportunities.
• Collaboration with an international team supporting biomedical research and diagnostics.