Compliance Specialist providing high - quality compliance advice to the business while supporting various departments. Conducting audits and assisting with regulatory requirements to uphold corporate governance policies.
About the role
- Project Compliance Officer validating new laboratory analysers and ensuring compliance with ISO standards at Preventx. Collaborating with teams to maintain high‑quality laboratory services.
Responsibilities
- Responsible for validating new laboratory analysers, assays, and operations systems
- Ensuring compliance with ISO 15189, ISO 27001, ISO 9001, ISO 14001, and Medical Device regulations
- Plan, write, and execute validation and verification protocols
- Perform validation studies including accuracy, precision, linearity, detection limits, measurement uncertainty
- Document all validation activities to meet ISO 15189 and internal QMS requirements
- Lead IQ/OQ/PQ processes for new equipment and software
- Participate in internal audits, external assessments, and CAPA processes
- Collaborate with laboratory, quality, IT, and supplier teams
Requirements
- Bachelor’s degree or equivalent experience
- Experience in laboratory
- Strong understanding of ISO 15189 accreditation requirements
- Experience in validation/verification of laboratory analysers, assays, or diagnostic systems
- Minimum 2 years’ laboratory experience
- Experience supporting compliance with ISO 27001, ISO 9001, and ISO 14001
- Knowledge of Medical Device Regulations / IVDR or device registration requirements
- Excellent technical documentation and report‑writing skills
- Ability to deliver training to laboratory or technical staff
Benefits
- Competitive salary
- Health insurance
- Professional development opportunities
- Flexible working arrangements
- Paid time off
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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