Regulatory Affairs Senior Specialist M/F

<p> </p> <p>We are <span><b>ZimVie</b></span>, a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth replacement and spine surgery solutions*. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves – their best selves – to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future, and we hope you’ll consider being a part of it!</p> <p> </p> <p><span><span><span><span><span><b><span><span><span><span>About the role:</span></span></span></span></b></span></span></span></span></span></p> <p><span><span><span><span>Lead and prepare technical documentation, including biocompatibility, clinical, and post-market surveillance reports. Assist the Global Regulatory Affairs Manager with topics related to clinical affairs, regulatory compliance, and regulatory affairs.</span></span></span></span></p> <p> </p> <p><span><span><b><span><span><span>What you’ll be doing:</span></span></span></b></span></span></p> <ul> <li><span><span><span><span>To prepare CERs for the Technical Documentations </span></span></span></span></li> <li><span><span><span><span>To prepare post-market surveillance reports</span></span></span></span></li> <li><span><span><span><span>To prepare biocompatibility reports</span></span></span></span></li> <li><span><span><span><span>Maintain and prepare Technical Documentations according to EU MDR requirements</span></span></span></span></li> <li><span><span><span><span>To review new regulatory requirements and implement them accordingly </span></span></span></span></li> <li><span><span><span><span>Support QMS maintenance including alignment with QMS of ZimVie </span></span></span></span></li> <li><span><span><span><span>Support R&amp;D in the development of new products </span></span></span></span></li> <li><span><span><span><span>To prepare and submit 510(k)</span></span></span></span></li> <li><span><span><span><span>To participate in External and Internal audits </span></span></span></span></li> </ul> <p> </p> <p><span><span><span><span><b><span><span><span>What you’ll need:</span></span></span></b></span></span></span></span></p> <ul> <li><span><span><span><span>University degree in a Science related subject (eg Biology, Biotechnology, Pharmacy, etc) </span></span></span></span></li> <li><span><span><span><span>5 years’ experience in a similar position</span></span></span></span></li> <li><span><span><span><span>SME in ISO 10993, ISO 14155, ISO 13485, EU MDR implementation, FDA 21 CFR 820 and submission of 510(k) </span></span></span></span></li> <li><span><span><span><span>Communications and organizational skills</span></span></span></span></li> <li><span><span><span><span>Fluent in English. Other European languages is a plus</span></span></span></span></li> <li><span><span><span><span>Initiative, flexibility and team player</span></span></span></span></li> <li><span><span><span><span>Possibility to travel to Spain, Italy and Germany</span></span></span></span></li> </ul> <p> </p> <p> </p> <p><span><span><span><span><b><span><span><span>What we offer:</span></span></span></b></span></span></span></span></p> <p><span><span><span><span>Working in a diverse and collaborative global team embracing innovative curiosity, personal authenticity, accountability, and a growth mindset. Our culture empowers us to bring our whole selves to work each day, so we can be at our best when serving our customers, patients, and colleagues.</span></span></span></span></p> <p><span><span><span><span>ZimVie offers you a challenging position with good career prospects in an international medical device business and following benefits:</span></span></span></span></p> <ul> <li><span><span><span><span><span><span>Competitive compensation package </span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Permanent contract</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Meal allowance</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Partially remote work option available </span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Private life, health and dental insurance</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Learning &amp; development program</span></span></span></span></span></span></li> </ul> <p> </p> <p> </p> <p> </p> <p><span><span><span><span><b><span><span><span>Do you want to know more about us?</span></span></span></b><span><span><span> Click </span></span></span><a href="https://vimeo.com/929122706"><span><span>HERE</span></span></a><span><span><span> to watch our story.</span></span></span></span></sp