Sr Regulatory Affairs Specialist EMEA - Industry
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Job Description Summary
As Senior Regulatory Affairs Specialist, you will play a crucial role in supporting our customers, for whom BD is the supplier, in their evaluation, selection, and continuous assessment processes.
This role is essential for maintaining BD's reputation for excellence in the Industrial Microbiology Business and supporting our commitment to quality and compliance.
Main Responsibilities
* Address customer queries to facilitate the qualification of BD as a supplier, focusing on product specifications, quality and product questionnaires, change notifications, quality agreements, and audits.
* Serve as the regulatory point of contact for industry clients and partners, ensuring clear and effective communication.
* Maintain and update the industry-specific RA repository, 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 for internal and external needs.
* Establish and maintain a robust compliance documentation filing system.
* Lead industry-specific regulatory projects and provide consultation on label review and approval processes to ensure alignment with regional and global regulatory standards. This includes establishing partnerships, joint initiatives, and OEM management. Conduct projects and any other duties based on emerging regulatory or environmental requirements or as needed to support customers.
* Act as a subject matter expert on animal by-product regulations, offering guidance to internal teams on importation regulatory standards and compliance issues.
* Review and approve advertising and promotional materials to ensure compliance with regulatory legislation, guidelines, and company standards.
* Build and maintain a system/database that tracks questions received per product.
About You
* Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field (Master’s degree preferred).
* 5-8 years of experience in regulatory affairs, preferably within the pharmaceutical, in vitro diagnostic medical device, or life sciences industries.
* Experience with EMEA regulatory standards and animal by-products regulation is strongly preferred.
* Strong understanding of EMEA legislation, standards, and regulatory frameworks, particularly in the pharmaceutical, biotech, and CRO sectors. Demonstrate effective knowledge in quality management systems and standards, ensuring product safety and efficacy.
* Highly proficient in English, both written and spoken; knowledge of French is an asset.
Click on apply if this sounds like you!
Why join us?
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our purpose, and it takes the imagination and passion of all of us—from design and engineering to manufacturing and marketing—to find transformative solutions.
At BD, you will have the opportunity to learn, grow, and thrive in an inclusive, growth-centered culture. Help shape the future of health and leave a legacy.
Our vision for Regulatory Affairs at BD
The Regulatory Affairs team helps ensure speed to market for BD’s innovative medical technologies with a patient-centric approach.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not discriminate based on race, color, religion, age, sex, creed, national origin, or other protected statuses.
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