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
We are looking for a Senior Regulatory Affairs Specialist to join our regulatory team located in Eybens (38). You will be responsible for ensuring the regulatory compliance of products and services for assigned countries and maintaining alignment with authorities, customers, and internal stakeholders. You will contribute to strategic regulatory analysis, monitor regulatory developments, and provide insights and recommendations to leadership.Job Description
Responsibilities
Contribute to international regulatory submission strategies (excluding US), while balancing compliance and business priorities.
Prepare and submit documentation to authorities to register/notify products (pharmaceuticals or combination products), ensuring compliance with global/local regulations.
Compile technical dossiers (e.g., eCTD Module 3 CMC) and manage post-market obligations.
Provide regulatory analysis for product launches and commercial communications.
Lead or support regulatory input for change controls and ensure continuous compliance.
Interact with regulatory authorities and internal partners, including during audits and tenders.
About You
Master's degree or higher in life sciences or scientific field (Pharmacist, Master in Regulatory Affairs).
Minimum 5 years of experience in the pharmaceutical and/or medical device industry.
Strong knowledge of regulatory requirements, particularly related to pharmaceuticals and eCTD submissions.
Fluent in English (spoken and written); additional EU language is a plus.
Strong analytical and communication skills; ability to work with both specialists and non-specialists.
Capable of managing multiple projects within deadlines and working collaboratively in cross-functional teams.
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 a maker of possible with 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
FRA GrenobleAdditional Locations
ESP San Agustin del GuadalixWork Shift
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed.
The salary or hourly rate offered to a successful candidate is determined by their experience, education, and skills, as well as the labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location.
Salary Range Information
€44,100.00 - €79,400.00 EUR AnnualSuccess 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.