Senior Regulatory Affairs & Quality Assurance Specialist | MedTech - MDx CRO
1 day ago
Bilbao
Senior Regulatory Affairs & Quality Assurance Specialist | MedTech 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 MedTech and IVD industry. We offer: • High-impact consulting projects with leading MedTech 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 principles: • Make it POSSIBLE, • Make it WIN-WIN, • Keep IMPROVING, • Keep GROWING, • Keep it DIVERSE Our Vision To democratise access to world-class regulatory and clinical strategies, ensuring safer and more effective medical technologies for all. Our Mission We pioneer emerging technologies and navigate uncharted territories to redefine the future of the medical sector. Grow with Us 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.