RA/QA specialist EMEA Industry

<h1>Job Description Summary</h1>As a global Medical Technology company, BD is dedicated to understanding and meeting the requirements for pharma, biotech, CROs and MD/IVD manufacturing, quality control, and compliance. <br/>The Regulatory Affairs Specialist will play a crucial role in supporting our customers, for whom BD is the supplier, in their evaluation, selection, and continuous assessment processes.<br/>You will be assisting customers in evaluating and selecting BD's products by providing the necessary Regulatory support to ensure BD is qualified as a supplier.<br/>You will be collaborating with industry customers to maintain strong partnerships and uphold BD's standards for quality and compliance.<br/>You will partner with the BDB industry team ensuring the right message is brought to the customers regarding the quality and regulatory capabilities.<br/><br/>This role is essential for maintaining BD's reputation for excellence in BDB Industry and supporting our commitment to quality and compliance.<p></p><p></p><h1>Job Description</h1><h2>Responsibilities</h2><ul><li><b>Address customer queries</b> to facilitate the qualification of BD as a supplier, focusing on product specifications, quality and product questionnaires and quality agreements.</li><li><b>Serve as the regulatory point of contact</b> for industry clients and partners.</li><li><b>Maintain and update the industry-specific RA repository</b>, including frequently requested information (FRI) for each manufacturing site, common statements, and product-specific animal origin documentation (e.g., Certificate of Suitability, TSE/BSE statements), to ensure timely and accurate records.</li><li><b>Support industry-specific regulatory projects</b> and provide consultation on label review and approval processes to ensure alignment with regional and global regulatory standards.</li><li><b>Act as a knowledgeable professional</b> on animal by-product regulations, offering mentorship to internal teams.</li><li><b>Review and approve advertising materials</b> to ensure compliance with regulatory legislation, guidelines, and company standards.<br/> </li></ul><h2>About you:</h2><ul><li>Bachelor’s degree in Life Sciences, Biomedical Engineering, or a similar field (Master’s degree is helpful).</li><li>Proven experience in regulatory affairs, preferably within the pharmaceutical, in vitro diagnostic medical device, or life sciences industries. Experience with EMEA in vitro diagnostic medical device regulation is strongly preferred.</li><li>Demonstrates knowledge application and problem-solving skills across a variety of standard situations. Resolves compliance issues and addresses regulatory queries.</li><li>Exhibits strong verbal and written communication skills.</li><li>Works optimally with moderate supervision, prioritizing tasks and determining work priorities.</li><li>Possesses a good understanding of EMEA legislation, standards, and regulatory frameworks, particularly in the pharmaceutical, biotech, and CRO sectors. Shows knowledge in quality management systems and standards, ensuring product safety and efficacy.</li><li>Highly proficient in English, both written and spoken.</li></ul><p></p><p></p><p></p><p>Required Skills</p><p>Optional Skills</p><p></p><p>.</p><h1>Primary Work Location</h1>ESP San Agustin del Guadalix<p></p><p></p><h1>Additional Locations</h1><p></p><p></p><h1>Work Shift</h1>