Temp QARA Specialist EMEA 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><strong><span><span><span>About the role:</span></span></span></strong></span></span></p> <p><span><span><span><span>This role will be responsible for performing duties to maintain regulatory compliance for products marketed by ZimVie, with a primary emphasis on communications with Competent Authorities. Responsibilities include the preparation and maintenance of Technical Documentation and participation in production transfers and new product development.</span></span></span></span></p> <p> </p> <p><span><span><strong><span><span><span>What you’ll be doing:</span></span></span></strong></span></span></p> <ul> <li><span><span><span><span>Registrations of products in EMEA area</span></span></span></span></li> <li><span><span><span><span>Maintain and update Health Authorities databases for Medical Device placing in the market and commercialization, as well as international internal databases on registrations.</span></span></span></span></li> <li><span><span><span><span>Provide requested documents to each subsidiary/distributor in the on a case-by-case basis and in accordance with National laws.</span></span></span></span></li> <li><span><span><span><span>Participation on external audits by NBs and Inspections by CAs and performance of internal audits to subsidiaries and supplier’s audits.</span></span></span></span></li> <li><span><span><span><span>Respond to all market requests (customers, subs, distributors and others).</span></span></span></span></li> <li><span><span><span><span>Support CS in providing information to customers</span></span></span></span></li> <li><span><span><span><span>Complete EU MDR Pre-incoming inspections </span></span></span></span></li> <li><span><span><span><span>Prepare the documentation required for custom clearance</span></span></span></span></li> <li><span><span><span><span>Participate in the assessments of the new or updated regulations and standards applicable to the products, and national laws for any new or updated revisions. Communicate updates to regulatory staff.</span></span></span></span></li> <li><span><span><span><span>Prepare, review, approve, distribution and training on QMS documentation.</span></span></span></span></li> <li><span><span><span><span>Give support to Medicovigilance (FSCA (Recalls) and FSN for EU area).</span></span></span></span></li> </ul> <p> </p> <p><span><span><strong><span><span><span>What you’ll need:</span></span></span></strong></span></span></p> <ul> <li><span><span><span><span>University degree in health of life science related subject.</span></span></span></span></li> <li><span><span><span><span>4 years in practical international medical device regulatory and quality experience. Experience with medical devices or similar is preferred. </span></span></span></span></li> <li><span><span><span><span>Certified Quality Auditor (CQA) preferred.</span></span></span></span></li> <li><span><span><span><span>Fluent in English &amp; Spanish. Other languages is a plus.</span></span></span></span></li> <li><span><span><span><span>MS Office.</span></span></span></span></li> </ul> <p> </p> <p><span><span><strong><span><span><span>What we offer:</span></span></span></strong></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>Competitive compensation package.</span></li> <li><span>Temporary contract until December 31, 2025</span></li> <li><span>Meal allowance</span></li> <li><span>Partially remote work option available</span></li> <li><span>Learning &amp; development program</span></li> <li><span>Employee Assistance Program (EAP)</span></li> </ul> <p> </p> <p><span><span><strong><span><span><span>Do you want to know more about us?</span></span></span></strong><span><span><span> Click </span></span></span><a href="https://vimeo.com/929122706"><span><spa