Senior Regulatory Affairs & Quality Assurance Specialist

Compliance MedQRA; Portugal; Remote; EUR 60,000 - 80,000; Full time

Job summary

Compliance MedQRA is seeking an experienced Senior Regulatory Affairs & Quality Assurance Specialist to join our remote, full-time consulting team. You will lead regulatory and quality projects for international clients, driving regulatory strategies and ensuring market access across medical devices, SaMD, IVDs, and pharma products.

Ideal candidates have 3–5 years of relevant experience, strong knowledge of EU MDR/IVDR and FDA requirements, and hands-on QMS implementation.

Qualifications

• 3–5 years of Regulatory Affairs and/or Quality Assurance experience in medical devices, SaMD, IVDs, or pharma.
• Strong knowledge of EU MDR/IVDR, FDA requirements and international frameworks.
• Experience preparing regulatory documentation, technical files and submissions.
• Hands-on QMS implementation and ISO 13485-aligned systems.
• Fluent English, excellent stakeholder management and remote-work capability.

Responsibilities

• Lead end-to-end regulatory and QA projects for international clients.
• Develop regulatory strategies across EU MDR/IVDR, FDA, UKCA, UAE/GCC.
• Prepare and review technical documentation and submissions (FDA 510(k), De Novo, Q-Sub).
• Design and maintain QMS environments, ISO 13485 alignment, and risk management.
• Coordinate audits, CAPA, change control, and post-market surveillance activities.
• Manage multiple client projects with clear communication and timelines.

Skills

Regulatory affairs

Quality assurance

Client communication

Project management

Remote work

Education

Bachelor's degree or higher

Tools

QMS software

Regulatory submissions tools

Job description

Compliance MedQRA is a growing international consultancy providing regulatory affairs and quality assurance services to medical device, SaMD, IVD, pharmaceutical, and life sciences companies.

We support clients throughout the product lifecycle, from regulatory strategy and market access to QMS implementation, certification, and post-market compliance.

We are also the developers of QraOne, an AI-enabled electronic Quality Management System (eQMS) designed to simplify compliance and streamline quality processes.

Role Description

We are looking for an experienced and proactive Senior Regulatory Affairs & Quality Assurance Specialist to join our growing consulting team, working remotely in a full-time capacity.

You will lead regulatory and quality projects for international clients across medical devices, SaMD, IVDs, pharmaceuticals, and related products, supporting regulatory compliance and successful market access.

Your responsibilities will include developing regulatory strategies, preparing and reviewing documentation, coordinating submissions under EU MDR, IVDR, FDA, and GCC/UAE requirements, and supporting post-market compliance. You will also contribute to the implementation and maintenance of ISO 13485-aligned quality management systems, risk management, internal audits, CAPA activities, and QMS documentation.

This role is ideal for a professional with 3–5 years of relevant experience who enjoys managing multiple projects, working directly with clients, and solving complex regulatory challenges in a dynamic consulting environment.

Key Responsibilities

• Lead and manage end-to-end regulatory affairs and quality assurance projects, ensuring timely delivery and high-quality outcomes.
• Develop and execute regulatory strategies across EU MDR/IVDR, FDA, UKCA, UAE/GCC, and other applicable international frameworks.
• Prepare, review, and manage technical documentation, design dossiers, and regulatory submissions, including FDA 510(k), De Novo, Q-Sub, and Breakthrough Device Designation pathways.
• Design, implement, maintain, and optimize Quality Management Systems (QMS), including eQMS environments, in alignment with ISO 13485.
• Drive ISO 13485 and MDSAP audit and certification readiness, including gap assessments, internal audits, mock audits, and audit preparation.
• Oversee design controls, software lifecycle documentation (IEC 62304), and risk management activities (ISO 14971).
• Lead CAPA, change control, nonconformity management, and audit remediation activities to ensure continuous compliance and improvement.
• Establish and maintain post-market surveillance (PMS) processes and ongoing regulatory compliance frameworks.
• Independently manage multiple client projects, including timelines, deliverables, risks, and stakeholder communication, while serving as a key client contact.
• Collaborate with multidisciplinary teams, mentor junior colleagues, and contribute to improving internal processes, methodologies, and consulting capabilities.

Requirements

• Based in the UK, Portugal, Spain, Greece, or Germany
• 3-5 years of experience in Regulatory Affairs and/or Quality Assurance within the medical device, SaMD, digital health, or related healthcare industries.
• Bachelor's degree or higher in Health Sciences, Biomedical Engineering, Biology, Pharmacy, or a related discipline.
• Strong knowledge of EU MDR/IVDR, FDA regulatory requirements, and applicable international regulatory frameworks.
• Proven experience preparing, reviewing, and maintaining regulatory documentation, technical files, and submissions.
• Hands-on experience implementing, maintaining, and improving Quality Management Systems (QMS), particularly ISO 13485-aligned systems and eQMS platforms.
• Strong understanding of MDSAP requirements, audit preparation, certification processes, and regulatory compliance.
• Experience conducting internal audits, gap assessments, CAPA activities, and supporting audit readiness and certification programs.
• Experience to independently manage multiple regulatory and quality projects, including planning, prioritization, timelines, and stakeholder coordination.
• Experience leading client-facing engagements, with excellent communication, interpersonal, and problem-solving skills.
• Fluent English, both written and spoken.
• Availability to work remotely in a full-time capacity, with occasional business travel as required.

Strong working experience in:

• EU MDR / IVDR;
• US FDA 510(k);
• Q-Submission (Q-Sub);
• Breakthrough Device Designation;
• UKCA requirement;s
• ISO 13485 QMS and MDSAP frameworks.

Nice to have:

• 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.
• Auditor qualification or auditing experience
• Experience in a consulting

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.

Language

Excellent command of English, both written and spoken. Knowledge of additional languages is an advantage.

Location

Remote - Based in the UK, Portugal, Spain, Greece, or Germany