Are you ready to make a difference in the healthcare sector? Do you have a keen eye for detail and a passion for regulatory compliance? Can you thrive in a dynamic, ever-evolving environment? We are currently looking for a Regulatory Affairs (RA) Specialist with proven experience in the Medical Devices industry and strong knowledge of ISO13485 regulations to join our busy team based in Wembley, London ! This is an exciting opportunity to play a pivotal role in ensuring our healthcare products meet the highest standards of compliance and quality. Hours of Work: Full-time & On-site RA Specialist Duties: As an RA Specialist, you will be instrumental in maintaining and promoting regulatory compliance across the organisation. Your responsibilities will include: Providing operational regulatory input to cross-functional teams Preparing crucial regulatory submissions Ensuring compliance documents align with ISO13485 requirements and are completed within designated timeframes Engaging in post-market surveillance activities and generating technical documentation Supporting international product registrations in line with Medical Device Regulations (MDR) Participating in audits and assisting with the development of Standard Operating Procedures (SOPs) RA Specialist Requirements: Experience in a regulatory affairs role within the Medical Devices industry Up-to-date knowledge of ISO13485 standards and regulatory frameworks such as MDD and MDR Strong attention to detail and organisational skills Ability to manage multiple tasks under tight deadlines Excellent problem-solving skills and a proactive approach RA Specialist Benefits: Competitive salary Opportunities for professional development and career advancement Supportive and collaborative work environment Contribution to meaningful projects that enhance patient safety Flexible working arrangements considered Meet the Organisation: Who We Are and What We Do At Medicareplus International, we are at the forefront of healthcare innovation, dedicated to ensuring the highest quality and regulatory standards for our products. Our team thrives on collaboration and continuous improvement, focusing on enhancing patient safety and advancing product innovation. If you think you are suitable for this RA Specialist role, apply now and be part of a team making a meaningful impact in healthcare! ADZN1_UKTJ