Senior Regulatory Affairs & Quality Assurance Specialist | MedTech

Location: Castro e Marzán

Senior Regulatory Affairs & Quality Assurance Specialist | Med Tech

Location:

Spain, Portugal and UK (Remote)

Employment type:

Full-time

Role Summary
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.

This role is ideal for professionals with

3–5 years of experience

who enjoy ownership, client interaction, and solving complex regulatory challenges within a fast-paced consulting environment.

Responsibilities
You will:
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
Contribute to the continuous improvement of internal processes, templates, and methodologies

You will enjoy a high degree of autonomy while receiving support from a collaborative team of experienced regulatory and clinical specialists.

Requirements (Must-Have)
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
Excellent client communication and interpersonal skills
Fluent English (written and spoken)
Availability for remote work with occasional travel, when required

Nice to Have
Experience in a consulting or CRO environment
Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, or other applicable medical device standards

Experience with international regulatory submissions
Spanish and/or Portuguese
Experience working with Software as a Medical Device (SaMD), AI-based medical devices, or IVDs
Auditor qualification or auditing experience

What Makes You a Great Fit
You are someone who enjoys taking ownership and making things happen.

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.

Why Join MDx CRO
At MDx CRO, you will join a dynamic and rapidly growing company recognised across the Med Tech and IVD industry. We offer:
High-impact consulting projects with leading Med Tech innovators
Significant autonomy and ownership from day one
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
Career progression opportunities within a fast-growing international company
Flexible remote working environment

About MDx CRO
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.

We operate on five core…