Regulatory Affairs Specialist
hace 28 días
Sheffield
Are you an experienced regulatory professional looking for your next long-term career move? I am partnering with an innovative, medical technology business to find a dedicated Regulatory Affairs Specialist to join their growing RAQA team on a permanent & 100% remote basis! In this pivotal role, you will champion global regulatory compliance, drive regulatory strategy, and ensure seamless market access for cutting-edge products across multiple regions. What You Will Be Doing: • Leading and managing critical regulatory submissions, with a primary focus on EU MDR technical files and FDA 510(k)., • Acting as the Person Responsible for Regulatory Compliance (PRRC) when required., • Producing and maintaining essential clinical (CEP, CER) and post-market surveillance (PMSP, PSUR) documentation., • Guiding cross-functional Product and Engineering teams to embed regulatory requirements directly into the product development lifecycle., • Managing vigilance activities and driving new regional product registrations. What You Bring to the Table: • A solid regulatory affairs background within the medical device sector., • Proven, hands-on success with EU MDR and FDA 510(k) submissions., • Deep working knowledge of ISO 13485:2016, MDSAP, ISO 14971, IEC 62304, and ISO 62366-1., • A relevant degree in Life Sciences, Biomedical Engineering, Computer Science, or RA., • Direct experience with Software as a Medical Device (SaMD) and an understanding of medical imaging modalities! If you are ready to take ownership of global regulatory strategies in a forward-thinking, collaborative environment, let’s talk!