Senior Quality & Regulatory Consultant

We are seeking a Senior Quality & Regulatory Consultant to lead complex, multi-market regulatory and quality engagements across EU, US, UAE/GCC, and UK.

This is a client-facing consulting role, not a traditional in-house position. You will work across multiple projects simultaneously, supporting Pharma, MedTech, SaMD, and AI-driven companies in achieving regulatory compliance, audit readiness, and global market access.

The role combines strategic regulatory leadership with hands-on QMS and audit execution, requiring strong ownership and the ability to operate in a fast-paced, multi-client environment.

• Lead end-to-end regulatory strategy and execution across EU MDR/IVDR, FDA, UKCA, and UAE/GCC frameworks
• Manage multiple client projects in parallel, ensuring high-quality delivery and timelines
• Drive ISO 13485 and MDSAP readiness, including certification and audit preparation as Lead Auditor
• Design, implement, and optimize Quality Management Systems (QMS), including eQMS environments
• Conduct internal audits, mock audits, and gap assessments, with clear, actionable outcomes
• Oversee and review:
• Technical Documentation / Design Dossiers
• Design Controls (including IEC 62304 for SaMD)
• Risk Management (ISO 14971)
• Lead CAPA, change control, and audit remediation activities
• Support and manage regulatory submissions and authority interactions, including:
• FDA (510(k), De Novo, Q-Submission, Breakthrough Designation)
• EU MDR / IVDR
• UKCA
• UAE (MOHAP / EDE) and GCC (SFDA)
• Establish and maintain post-market surveillance (PMS) and compliance frameworks
• Mentor junior team members and contribute to internal capability building
  

• 5–7+ years of experience in Quality & Regulatory Affairs within:
• Medical Devices
• SaMD / Digital Health / AI-based systems
• Pharmaceutical or combination products (nice to have)
• Proven experience in:
• Managing multiple regulatory and quality projects simultaneously
• Leading client-facing engagements
• Driving audit readiness and certification programs
• Strong working knowledge of:
• ISO 13485 & QMS implementation
• MDSAP requirements and audit approach
• eQMS platforms and digital quality systems
  

• Certified Lead Auditor (ISO 13485 or equivalent)

Hands-on experience in:

• ISO 13485 certification audits and MDSAP audits
• Internal and external audits
• Regulatory inspections
• Proven ability to:
• Lead audit teams
• Drive CAPAs and remediation strategies
• Coordinate cross-functional audit activities
  

Strong working experience in:

• EU MDR / IVDR
• US FDA regulatory pathways including:
• 510(k)
• De Novo
• Q-Submission (Q-Sub)
• Breakthrough Device Designation
• UKCA requirements
• ISO 13485 QMS and MDSAP frameworks

• Experience with:
• SaMD and AI-enabled medical technologies
• EU AI Act understanding and implementation
• UAE / GCC regulatory frameworks (MOHAP, EDE, SFDA)
• Familiarity with:
• IEC 62304 (Software Lifecycle)
• ISO 14971 (Risk Management)
• Experience working in a consulting or multi-client environment
  

• Strong ownership mindset, ability to lead and deliver independently
• Balance of strategic thinking and hands-on execution
• Excellent client communication and stakeholder management
• Structured, solution-oriented approach to complex regulatory challenges
• Ability to work in a remote, fast-paced, international environment
  

Remote (preference for candidates based in the EU)

Apply via LinkedIn or send your CV to [Confidential Information]