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 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.
Job Description
Main responsibilities will include:
- Address customer queriesto 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 contactfor 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.
- Establishing and maintaining a robust compliance documentation filing system
- Lead industry-specific regulatory projectsand 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. Conducting projects and any other duties based on emerging regulatory or environmental requirements or as needed to support customers.
- Act as a subject matter experton animal by-product regulations, offering guidance to internal teams on importation regulatory standards and compliance issues.
- Review and approve advertising and promotional materialsto ensure compliance with regulatory legislation, guidelines, and company standards.
- Building andmaintaining a system/databasethat tracks and gives an overview of the 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.
- Possesses a 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; with another language (French) being an asset.
Click on apply if this sounds like you!
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become amaker of possiblewith us!
Our vision for Regulatory Affairs at BD
The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric attitude.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
To learn more about BD visit:https://bd.com/careers
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.