GxPeople Global

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 (phone number removed) . 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!