About the Role
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<div>🚀 <strong>Senior Regulatory Affairs Specialist | Advanced Wound Care & Infection Prevention</p>
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<div> 📍 <strong>NW</strong> <strong>London</strong> (office based 5 days per week)<br /> 💰 £56K + Bonus + Excellent Benefits</div>
<div><strong>Strong knowledge of EU MDR 2017/745 & ISO 13485 required</p>
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<div>Looking for a regulatory role where your work directly supports products that improve patient outcomes?</div>
<div><strong>Learning and development supported – clear progression!</p>
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<div>The company is a well-regarded SME and a leading force in advanced wound care and infection prevention, with a product portfolio backed by strong clinical evidence. </p>
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<div><strong><br />🔥 Why This Role?</strong></div>
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<li>Senior RA position with real ownership and influence</li>
<li>Innovative medical device SME with a strong reputation</li>
<li>Key role supporting EU MDR compliance and product growth</li>
<li>Diverse, clinically meaningful wound care portfolio</li>
<li>Clear progression and ongoing development opportunities</li>
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<div><strong><br />💼 What You’ll Do</strong></div>
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<li>Lead and maintain EU MDR technical documentation</li>
<li>Support Class I to Class II product transitions</li>
<li>Collaborate with Clinical, R&D, Marketing and Operations teams</li>
<li>Manage regulatory submissions and compliance activities</li>
<li>Engage with Notified Bodies and Competent Authorities</li>
<li>Help shape global regulatory strategy</li>
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<div><strong><br />👊 Who You Are</strong></div>
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<li>3+ years’ medical device regulatory experience</li>
<li><strong>Strong knowledge of EU MDR 2017/745 & ISO 13485 </strong></li>
<li>Experienced with technical documentation</li>
<li>Detail-focused, proactive and commercially aware</li>
<li>Excellent stakeholder management skills</li>
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<div><strong><br />💰 The Package</strong></div>
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<li>£52-56K basic</li>
<li>5% annual bonus</li>
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<div>25 days holiday + bank holidays</div>
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<div>📩 <strong>Ready to take ownership of a high-impact regulatory portfolio? Apply now.</strong></div>
<p><img src="https://counter.adcourier.com/bWVkaWNhbC45NzMyMi4xMzEwOEBibXMuYXBsaXRyYWsuY29t.gif"></p>