Senior Regulatory Affairs Specialist (m/f/*)

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: <span>https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/</span> continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.<p></p><p></p><p><b>Job Description:</b></p><p></p><p><b><span>3M Health Care is now Solventum</span></b></p><p></p><p><b>At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. </b></p><p></p><p><b>We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.</b></p><p></p><p><b>The Impact You’ll Make in this Role</b></p><p></p><p>As a <b>Senior Specialist Regulatory Affairs (m/f/*)</b>, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:</p><ul><li><span>Acting as liaison between design center regulatory affairs, regulatory consultants and distributors to enable registrations in select<span> </span>EMEA countries </span></li><li><span>Managing compliance projects, developing and implementing regulatory strategies and submissions for medical devices in select EMEA countries </span></li><li><span>Ensuring compliance with country regulatory requirements for market access and vigilance of medical devices</span></li><li><span>Implementing regulatory strategies during product development/ introduction and /or product modification, ensuring all changes reflected in country registrations including correct labelling</span></li><li><span>Preparing and maintaining regulatory documents for registration submissions</span></li><li><span>Communicating to authorities, notified bodies, consultants and distributors etc. </span></li><li><span>Preparing country-specific documentation requests for registrations, bid &amp; tenders &amp; reimbursement<span>  </span></span></li><li><span>Monitoring emerging regulations affecting medical devices in select EMEA <span> </span>countries.</span></li></ul><p></p><p></p><p><b>Your Skills and Expertise  </b></p><p>To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:</p><ul><li>Scientific university degree (Dipl., Master, Bachelor) or a comparable qualified education.</li><li>Extensive experience in regulatory affairs in the medical device or pharmaceutical industry.</li><li>Ideally, you have knowledge of the medical device regulations and standards including EN ISO 13485, EU MDR 2017/745, GMP, etc.</li><li><span>Ability to work in cross-functional and cross-cultural teams<span>  </span></span></li><li><span><span>Good communication and decision-making skills</span></span></li><li><span><span>Ability to negotiate with<span>  </span>regulatory agencies and notified bodies </span></span></li><li><span><span>Ability to use databases and regulatory submission request tools<span>  </span></span></span></li><li><span><span>Fluent English language skills, both written and verbal</span></span></li><li><span><span>Additional EMEA languages are a plus</span></span></li></ul><p></p><p></p><p><b>Work location: </b></p><ul><li><b>Hybrid in Wroclaw or remote within Poland</b></li></ul><p></p><p><b>Travel: May include up to 5</b><b>% domestic &amp; international</b></p><p></p><p><b>Must be legally authorized to work in country of employment without sponsorship for employment visa status.</b></p><p></p><p><b>Supporting Your Well-being</b> </p><p>Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. </p><p></p><p><b>Diversity &amp; Inclusion</b></p><p>(*) We are an equal opportunity employer and