Senior Regulatory Affairs Specialist (Medical Devices) (f/m/d) - Fixed-Term for 2 Years

<span id="requisitionDescriptionInterface.reqTitleLinkAction.row1" title="">Senior Regulatory Affairs Specialist (Medical Devices) (f/m/d) - Fixed-Term for 2 Years </span><span id="requisitionDescriptionInterface.ID1326.row1" title="">-</span><span id="requisitionDescriptionInterface.reqContestNumberValue.row1" title="">2407027967W</span><p></p><h2 xmlns:ftl="http://www.taleo.net/ftl" xmlns:htm="http://www.w3.org/1999/xhtml" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"><span>Description</span></h2><span><span> </span></span><span id="requisitionDescriptionInterface.ID1388.row1" title=""><p><u><span></span></u></p> <p><span>Kenvue is currently recruiting for: </span></p> <p><b><span>Senior Regulatory Affairs Specialist (Medical Devices) (f/m/d) – Fixed-Term for 2 Years</span></b></p> <p><span>The role reports into the Senior Manager Regional Essential Health and is based at Neuss, Germany (hybrid).</span></p> <p><span> </span></p> <p><b><span>Who We Are</span></b></p> <p><span>At </span><span><a href="https://www.jnj.com/kenvue"><span>Kenvue</span></a></span><span> we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives.  Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.</span></p> <p><b><span>What You Will Do</span></b><span> </span><span></span></p> <p><span>The Senior Regulatory Affairs Specialist is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Essential Health franchise.</span></p> <ul type="disc"> <li><span>Evaluates and coordinates the regulatory deliverables for medical device</span></li> <li><span>Develops effective partnerships with R&amp;D, Franchise (Marketing) and local regulatory colleagues</span></li> <li><span>Assists in the preparation of technical files and submission packages for the certification and maintenance of products throughout their whole lifecycle</span></li> <li><span>Represents the Regulatory Affairs function as appropriate within the Essential Health Franchise </span></li> </ul> <p><b><u><span>Key Responsibilities </span></u></b></p> <p><b><span>Regulatory Strategy</span></b><span></span></p> <ul type="disc"> <li><span>Works with local and regional regulatory colleagues to develop global and/or regional regulatory</span></li> <li><span>strategies, coordinating regulatory actions and results and develops global/regional dossiers to support local review processes</span></li> <li><span>Provide regulatory advice and perform due diligence for product acquisitions and distributor</span></li> <li><span>agreements with third parties</span></li> <li><span>Organizes materials from preclinical and clinical studies for review and assists in the review process</span></li> <li><span>Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines</span></li> <li><span>Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings</span></li> <li><span>Tracks the status of applications under regulatory review and provides updates to the regulatory team</span></li> <li><span>Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at regional level</span></li> </ul> <p><b><span>Regulatory Compliance</span></b><span></span></p> <ul type="disc"> <li><span>Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders</span></li> <li><span>Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments</span></li> <li><span>Participate in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs and working instructions</span></li> <li><span>Ensures that the enterprise Regulatory systems are accurate and fully maintained</span></li> <li><span>Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally</span></li> <li><span>Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives</span></li> <li><span>Support internal and external audits and inspections in collaboration with quality function</span></li> </ul> <p><b><span>Regulatory Advocacy</span></b><span></span></p> <ul type="disc"> <li><span>Monito