Regulatory & Quality Systems Consultant_Medical Devices

Key Responsibilities

• Plan, scope, and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit.
• Evaluate the medical device manufacturer’s Quality Management System (QMS) against ISO 13485:2016 and the EU MDR 2017/745.
• Conduct rigorous onsite or virtual stress-testing of core QMS processes:
• Management Responsibility & Resource Management
• Design and Development / Technical Documentation Files
• Production and Service Provision (Cleanroom, Sterilization, Validation)
• CAPA, Complaint Handling, and Post-Market Surveillance (PMS)
• Review Technical Files and Design History Files (DHF) to ensure alignment with BSI expectations.
• Prepare detailed mock audit reports, classifying findings into Major and Minor nonconformances using Notified Body criteria.
• Provide a definitive gap analysis report outlining critical vulnerabilities and immediate remediation strategies.
• Debrief leadership and process owners on audit outcomes, providing actionable guidance on how to interface with BSI auditors.
• Assess the readiness of subject matter experts (SMEs) through simulated front-room/back-room interview dynamics.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum 8 years of experience in the Medical Device industry, specifically in Quality Assurance or Regulatory Affairs.
• Certified ISO 13485 Lead Auditor (IRCA, Exemplar Global, or equivalent).
• Proven track record of preparing medical device manufacturers for successful Notified Body audits, specifically with BSI.
• Deep, current knowledge of ISO 13485:2016, ISO 14971 (Risk Management), and European medical device regulations.
• Strong analytical, interviewing, and technical report-writing skills.
• Ability to deliver objective, critical feedback constructively under tight preparation timelines.

Preferred Qualifications

• Former BSI Lead Auditor experience is highly preferred.
• Hands-on experience managing a front-room/back-room during a live BSI QMS audit.
• Experience auditing the specific device risk classification and technology relevant to our product portfolio.
• Familiarity with MDSAP requirements.