Senior Regulatory Affairs & Quality Assurance Specialist | MedTech

Senior Regulatory Affairs & Quality Assurance Specialist | Med Tech

Revise detenidamente toda la documentación de la solicitud antes de hacer clic en el botón de solicitar al final de esta descripción.
Spain, Portugal and UK (Remote)
Full-time

We are looking for an experienced and proactive Regulatory Affairs & Quality Assurance professional to join our growing consulting team.

As a Senior Regulatory Affairs & Quality Assurance Specialist , you will lead regulatory and quality projects for medical device manufacturers, helping clients navigate complex regulatory requirements and implement robust quality systems that enable successful market access.

You will work directly with international clients, leading multiple projects simultaneously while collaborating with multidisciplinary experts across regulatory affairs, quality assurance, clinical research, and medical writing.

Lead and manage Regulatory Affairs and Quality Assurance projects from planning through successful delivery
Perform regulatory and quality gap assessments and develop practical compliance strategies
Prepare, review, and maintain technical and regulatory documentation for medical devices
Coordinate and support regulatory submissions across global markets
Support the implementation, maintenance, and continuous improvement of Quality Management Systems (QMS)
Provide regulatory and quality guidance aligned with MDR, FDA, and other applicable international requirements
Manage project timelines, priorities, risks, and stakeholder communication
Act as the primary point of contact for clients throughout project execution
Collaborate with internal multidisciplinary teams to deliver high-quality consulting services
You will enjoy a high degree of autonomy while receiving support from a collaborative team of experienced regulatory and clinical specialists.

Based in Spain or eligible for a Spanish employment contract
~3–5 years of experience in Regulatory Affairs and/or Quality Assurance within the Medical Device industry
~ Bachelor's degree (or higher) in Health Sciences, Biomedical Engineering, Biology, Pharmacy, or a related discipline
~ Strong knowledge of European Medical Device Regulation (EU MDR) and FDA regulatory requirements
~ Experience preparing and reviewing regulatory and quality documentation
~ Experience supporting or leading Quality Management System implementation and maintenance
~ Strong project management skills, including planning, prioritization, and stakeholder coordination
~ Ability to independently manage multiple projects simultaneously
~ Fluent English (written and spoken)
~ Availability for remote work with occasional travel, when required

Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, or other applicable medical device standards
Spanish and/or Portuguese
Experience working with Software as a Medical Device (SaMD), AI-based medical devices, or IVDs
You learn quickly, communicate confidently with clients, and are comfortable managing several complex projects at the same time. Rather than waiting for direction, you proactively identify solutions and drive projects forward.

You enjoy consulting because every project presents a new challenge, and you are motivated by helping innovative medical technologies reach patients safely and efficiently.

Most importantly, you combine technical expertise with strong organizational skills and a collaborative mindset, consistently delivering high-quality work while building trusted relationships with clients and colleagues.

High-impact consulting projects with leading Med Tech innovators
Exposure to international regulatory and quality challenges
Continuous professional development and training
Collaboration with experienced specialists across Regulatory Affairs, Clinical Research, Medical Writing, and Quality Assurance
Flexible remote working environment

MDx CRO is a leading Contract Research Organisation specialising in medical devices and in vitro diagnostics (IVDs). We provide regulatory consulting, clinical research, medical writing, and quality assurance services, helping manufacturers bring innovative healthcare technologies to market while ensuring full compliance with global regulatory requirements. xsgfvud

We pioneer emerging technologies and navigate uncharted territories to redefine the future of the medical sector.

If you are looking to take the next step in your Regulatory Affairs and Quality Assurance career, enjoy working with innovative medical technologies, and want to make a meaningful impact through consulting, we'd love to hear from you.