Senior Regulatory & Quality Assurance Lead - Remote

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 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.