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 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. Key Competencies BSI Audit Readiness & Notified Body Interface Rigorous Gap Analysis & Nonconformance Classification Risk-Based Auditing & Technical File Evaluation SME Coaching & Interview Preparation Objective, High-Pressure Stakeholder Communication #J-18808-Ljbffr