Senior Specialist Regulatory Affairs

<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>JOB DESCRIPTION:</b></h2><p>Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.</p><p></p><p><b><u>Working at Abbott</u></b> </p><p>At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:  </p><ul><li><p>Career development with an international company where you can grow the career you dream of. </p></li><li><p>Competitive salaries, bonus potential and excellent package of benefits.</p></li><li><p>A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.</p></li><li><p>A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.</p></li></ul><p></p><p><b>About the Role</b></p><p>Abbott Rapid Diagnostics (ARDx) is seeking a <u>Senior Specialist, Regulatory Affairs </u>to serve as a regional regulatory expert supporting Eastern Europe, EEA, CEE, broader Europe, and Turkey; to be based in Warsaw, Poland.</p><p></p><p>This role is a senior individual contributor position with significant responsibility for enabling commercialization, supporting go‑to‑market strategies, and ensuring compliance with IVDR and applicable local regulations.</p><p><b>Senior Specialist</b> will act as a strategic interface between Regulatory Affairs and Commercial/Marketing teams, legal manufacturers and the cross functional team supporting product launches, promotional compliance, and lifecycle management.</p><p></p><p><b>Key Responsibilities</b></p><ul><li><p>Act as a regional regulatory expert for EE/EEA/CEE and Turkey</p></li><li><p>Provide strong IVDR expertise, including regulatory intelligence and lifecycle/change management</p></li><li><p>Serve as a strategic regulatory partner to global team, Commercial and Marketing, including promotional material review, claim alignment, and launch readiness</p></li><li><p>Ensure product registrations and market access activities while ensuring governance, compliance, and audit readiness</p></li></ul><p></p><p>Regulatory Oversight of Commercial Activities:</p><ul><li><p><u>Submissions, Commercialization &amp; Market Access</u>: Support product registrations and notifications; ensure launch readiness; provide regulatory documentation for tenders, distributors, and customers.</p></li><li><p><u>Lifecycle &amp; Change Management: </u>Communicate regulatory changes; assess commercial impact of variations, discontinuations, and supply changes; support UDI and EUDAMED implementation.</p></li><li><p><u>Review and approve promotional and commercial materials</u>: ensure labels, claims, and messaging align with CE‑marked indications and approved technical documentation.</p></li><li><p><u>Regulatory–Commercial Interface</u>: Act as primary regulatory partner to Sales, Marketing, global regulatory and Commercial teams; provide training and regulatory guidance.</p></li><li><p><u>Governance, Compliance &amp; Quality</u>: Ensure compliance with EU regulations , other applicable regulations in the region and internal procedures; support audits, PMS, vigilance, and QMS maintenance.</p></li><li><p><u>Regulatory Intelligence</u>: Monitor evolving IVD regulations; assess portfolio impact; maintain strong relationships with authorities and industry associations.</p></li></ul><p></p><p><b><u>Required qualifications &amp; background:</u></b></p><ul><li><p>Education: Bachelor’s degree or equivalent in medical, biomedical, pharmaceutical, or other science‑related field. ISO 13485 training is an advantage.</p></li><li><p>Experience: Minimum 7 years of Regulatory Affairs experience in IVD or medical devices with deep IVDR/MDR expertise.</p></li><li><p>Strong understanding of EU regulations governing registration, promotional materials, vigilance, and customer‑facing communications.</p></li><li><p>Proven ability to lead complex cross‑functional projects and support commercial objectives.</p></li><li><p>Languages: Fluent English required; German, Polish, French, Spanish, or other European languages are a strong asset.</p></li><li><p>Skills: Excellent organizational, analytical, communication, and stakeholder‑influencing skills; proficiency in Microsoft Office tools.</p></li></ul><p></p><p>Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.</p><p></p><p>Connect with us at <a href="http://www.abbott.com/" target="_blank">www.abbott.com</a>, on Facebook at <a href="http://www.facebook.com/Abbott" target="_blank">www.facebook.com/Abbott</a> and on Twitter &#64;AbbottNews and &#64;AbbottGlobal.</p><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p><b>The base pay for this position is </b></p>N/A<p style="text-align:left"><span>In specific locations, the pay range may vary from the range posted.</span></p><p style="text-align:inherit">     </p><h2><b>JOB FAMILY:</b></h2>Regulatory Operations<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>DIVISION:</b></h2>ID Infectious Disease<p style="text-align:inherit">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</p><h2><b>LOCATION:</b></h2>Poland &gt; Park Postepu : Building B<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>ADDITIONAL LOCATIONS:</b></h2><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>WORK SHIFT:</b></h2>Standard<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>TRAVEL:</b></h2>Not specified<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>MEDICAL SURVEILLANCE:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>SIGNIFICANT WORK ACTIVITIES:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p style="text-align:inherit">     </p><p style="text-align:inherit">     </p>