Regulatory Affairs Specialist

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