Senior Regulatory Affairs Specialist

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    "datePosted": "2026-04-27",
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    "description": "<p>At AROA, our people come to work every day with passion and ideas that fuel our business and go home knowing they have made a real difference in the lives of others.</p>\n<p><br></p>\n<p>AROA, which is Maori for ‘understanding’, is proudly New Zealand born and based. We develop, manufacture, and export innovative wound care products, improving the lives of millions around the world by unlocking extraordinary outcomes for our patients. Our mission is to be the global leader in regenerative healing, making our products and services accessible to everybody. <br><br></p>\n<p><span style=\"font-weight: bold\">About the role:<br></span>As a Senior Regulatory Affairs Specialist (Fixed Term – 12 months Parental Leave Cover), you’ll support global market authorisations for a range of medical devices across key markets. You’ll be responsible for delivering high quality regulatory submissions, maintaining existing approvals, and supporting ongoing compliance activities across the product lifecycle. In this role you will:</p>\n<ul>\n<li>Lead global regulatory submissions aligned to registration strategies</li>\n<li>Coordinate requirements with internal teams and external regulators</li>\n<li>Manage responses to queries, deficiencies, and agency feedback</li>\n<li>Support product release following regulatory approvals</li>\n</ul>\n<p> </p>\n<p>As a Regulatory SME, you will:</p>\n<ul>\n<li>Shape regulatory strategy through interpretation of global requirements</li>\n<li>Influence design, risk, testing, labelling, and compliance decisions</li>\n<li>Review change controls, claims, and labelling for compliance</li>\n<li>Support post-market surveillance and product lifecycle activities</li>\n<li>Contribute to FDA 510(k) and Global submissions</li>\n<li>Support renewals and ongoing market authorisations</li>\n</ul>\n<p> </p>\n<p><span style=\"font-weight: bold\">What you’ll bring:</span></p>\n<p>You are an experienced medical device Regulatory Affairs professional with a relevant degree and 5+ years’ direct regulatory experience. You also bring: </p>\n<ul>\n<li>Strong experience across active devices, software, and sterile/single-use consumables</li>\n<li>Confidence operating across complex international regulatory frameworks</li>\n<li>You have independently authored at least two successful FDA 510(k) submissions</li>\n<li>Experience managing multi-market submissions with a high degree of autonomy</li>\n<li>Credible regulatory expert with strong technical writing ability and exceptional attention to detail</li>\n<li>Confidence to influence stakeholders and deliver outcomes in a fast-paced environment.</li>\n</ul>\n<ul>\n<li>Experience compiling technical files and documentation</li>\n</ul>\n<p><br></p>\n<p><span style=\"font-weight: bold\">What we offer:</span></p>\n<ul></ul>\n<p>At AROA NZ, we value our people and make sure working with us is rewarding, both professionally and personally. Here’s what you can enjoy as part of our team:</p>\n<ul>\n<li><span style=\"font-weight: bold\">Convenient Location</span> – Free carparking onsite at our Airport Oaks sites with easy motorway access.</li>\n<li><span style=\"font-weight: bold\">Career Growth &amp; Impact</span> – Be part of a mission-led company doing work that’s never been done before, with opportunities for learning, development, and real impact.</li>\n</ul>\n<p><br></p>\n<p>To be considered for this opportunity you must have existing NZ working rights.</p>",
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