Faites partie de quelque chose de plus grand chez BD. Ici, vous nous aiderez à maintenir nos normes élevées d'un point de vue réglementaire à tous les niveaux, avec un accent particulier sur les soumissions. Cela exige une attention aiguë aux détails, d'excellentes compétences en communication et une passion pour continuer à apprendre et à mettre à jour vos connaissances, ce que nous vous aiderons à faire avec des opportunités d'apprentissage régulières. Ici, vous utiliserez vos connaissances approfondies des réglementations et des exigences de la FDA, du Canada et de l'ISO/MDD entourant les dispositifs médicaux pour atteindre finalement un objectif unique : faire progresser le monde de la santé™. Chez BD, vous pouvez faire une véritable différence d'une personne.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
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.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.
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.
You will be collaborating with industry customers to maintain strong partnerships and uphold BD's standards for quality and compliance.
You will partner with the BDB industry team ensuring the right message is brought to the customers regarding the quality and regulatory capabilities.
This role is essential for maintaining BD's reputation for excellence in BDB Industry and supporting our commitment to quality and compliance.
Job Description
Responsibilities
- Address customer queries to facilitate the qualification of BD as a supplier, focusing on product specifications, quality and product questionnaires and quality agreements.
- Serve as the regulatory point of contact for industry clients and partners.
- 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.
- Support industry-specific regulatory projects and provide consultation on label review and approval processes to ensure alignment with regional and global regulatory standards.
- Act as a knowledgeable professional on animal by-product regulations, offering mentorship to internal teams.
- Review and approve advertising materials to ensure compliance with regulatory legislation, guidelines, and company standards.
About you:
- Bachelor’s degree in Life Sciences, Biomedical Engineering, or a similar field (Master’s degree is helpful).
- 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.
- Demonstrates knowledge application and problem-solving skills across a variety of standard situations. Resolves compliance issues and addresses regulatory queries.
- Exhibits strong verbal and written communication skills.
- Works optimally with moderate supervision, prioritizing tasks and determining work priorities.
- 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.
- Highly proficient in English, both written and spoken.
Required Skills
Optional Skills
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Primary Work Location
ESP San Agustin del GuadalixAdditional Locations
Work Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.