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
The Regulatory Affairs Intern, EMEA Regulatory Operations, will learn and develop through executing and supporting regulatory activities across BDx and all EMEA countries.Under close supervision, the intern will assist in executing regulatory As Regulatory Affairs Trainee you will will learn and develop through executing and supporting regulatory activities across BDx and all EMEA countries.
Under close supervision, the intern will assist in executing regulatory processes, maintaining tools, systems, and metrics, and facilitating communication with internal and external stakeholders. The role also involves contributing to process harmonization and supporting both the Regulatory Affairs Support Team (RAST) and the broader EMEA regulatory team as needed.
The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.
Job Description
Main responsibilities will include:
- Support, under supervision:
- Preparation, implementation and maintenance of harmonised regulatory documents within BD quality management system (e.g. procedures, work instructions, training matrix, change controls, CAPAs) to ensure compliance with regulatory and corporate requirements.
- Creation, implementation and maintenance of regulatory tools and databases to support EMEA BDX RA processes and activities execution and facilitate collaboration within EMEA RA organization and with key stakeholders.
- Data management (metrics & dashboards) relevant to EMEA RA organisation and its stakeholders
- Regulatory Affairs Support Team (RAST) in handling EMEA BDx Customer & Tender Queries, importation requests and obtaining Certificates of Free Sale (CFS) within EMEA, including invoicing and consular services
- Understand and follow local, regional, and corporate procedures applicable to role.
- Understand BD culture and values and reflect them in his/ her own behavior.
- Effectively navigate organizational dynamics and collaborate with various teams, including but not limited to EMEA RA, and EMEA commercial teams.
- Support the wider EMEA regulatory affairs team as required
About you
- Educated to a Bachelor’s Degree, preferably in scientific or engineering field
- Internship Agreement with the University is required.
- Advanced in spoken and written English.
- Self-motivated. Ability to work effectively both individually and as part of a team with high oversight.
- Organized, analytical thinker with good attention to detail. Able to translate problems into solution and to use data to recommend business decisions within regulatory affairs.
- Good computer skills (Proficient with Microsoft Excel, Word, Outlook, PowerPoint, Data Management - PBI is a plus).
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!
Click on apply if this sounds like you!
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.