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 general 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 collab