Regulatory & Quality Systems Consultant_Medical Devices

VOLTO Consulting; Austin (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

VOLTO Consulting is looking for a qualified candidate to oversee BSI readiness audits in Austin, Texas. You will be responsible for planning, scoping, and leading mock audits for a variety of medical device manufacturers, ensuring compliance with ISO 13485:2016 and EU MDR 2017/745.

The ideal applicant should possess a Bachelor's degree in a relevant field and at least 8 years of experience in Quality Assurance or Regulatory Affairs. Strong analytical skills and the ability to provide constructive feedback are a must.

Qualifications

• Minimum 8 years of experience in the Medical Device industry.
• Certified ISO 13485 Lead Auditor (IRCA, Exemplar Global, or equivalent).
• Deep knowledge of ISO 13485:2016 and EU medical device regulations.

Responsibilities

• Plan and lead mock audits for BSI notified body.
• Evaluate QMS against ISO standards.
• Prepare detailed mock audit reports.

Skills

Analytical skills

Interviewing skills

Technical report writing

Objective feedback delivery

Education

Bachelor’s degree in Engineering, Life Sciences or related field

Job description

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