Senior Quality & Regulatory Specialist

Company Description

ComplianceMedQRA provides regulatory and quality consulting services to medical device, software, pharmaceutical, and life sciences organizations across the full product lifecycle, from early regulatory strategy to market authorization and post-market compliance. The team’s expertise covers EU MDR, IVDR, FDA pathways, SaMD, AI-enabled medical devices, and GCC/UAE frameworks, including MOHAP/EDE, UAE PDPL, and healthcare data security requirements.

The company also offers QraOne, an AI-enabled eQMS platform designed for MedTech, SaMD, IVD, and life sciences organizations, translating regulatory and quality experience into automated workflows that streamline compliance and improve audit readiness across EU, U.S., and GCC regulations.

Role Overview

We are seeking a Senior Quality & Regulatory Specialist 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.

Key Responsibilities

• 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

Required Experience

• 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
• Audit and Certification Expertise
• 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
• Core Regulatory Expertise (Expected)

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

Preferred / Added Advantage

• 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

What We Value

• 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

Location

Remote

Interested?

Apply via LinkedIn or send your CV to [email protected]