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
Being a key strategic partner for the EMEA BD Business by (i) supporting the implementation of registration/regulatory strategies for the UCC-SRG portfolios, closely aligned with the region's commercial objectives, to meet EMEA market requirements and (ii) securing local markets by maintaining local licenses compliant with changes related to local/global regulations or changes to the product(s).Job Description
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!
About the role
Being a key strategic partner for the EMEA BD Business by (i) supporting the implementation of registration/regulatory strategies for the UCC-SRG portfolios, closely aligned with the region's commercial objectives, to meet EMEA market requirements and (ii) securing local markets by maintaining local licenses aligned with changes related to local/global regulations or changes to the product(s).
Main responsibilities will include:
Navigate within the BD matrix organization to ensure a close alignment between the Region regulatory strategies and Business Unit (BU) and Country Regulatory Affairs (RA) teams’ objectives
Assemble technical information, by interacting with BU RA as necessary, to create Registration and/or Notification Dossiers in compliance with local requirements. Support regulatory submissions to Regulatory Agencies as appropriate by collaborating with Country RA to ensure a faster time to market and align with the registration/renewal objectives approved by eIPPRA.
Lead the Registration planning and prioritization in EMEA to drive alignment with the Business.
Complete product launch plan, upcoming renewals and amendments of registration licenses due to products changes and regulatory re-registrations of new local regulations/requirements of existing BD products already registered in the EMEA region. Execution in accordance with the Registration planning and prioritizations defined in close collaboration with the EMEA Marketing Team and supported by approved eIPPRA submissions.
Conduct Impact Assessments for Product changes and Regulation changes in EMEA to ensure continued compliance with Regulations
Release BD products to the market in compliance with their country registration status in EMEA
Ensure Regulatory Information Management (RIM) system, internal EMEA Registration databases and specific project trackers related to the RA activities are maintained and up-to-date
Lead and/or represent the EMEA RA team by joining project teams to anticipate regulatory risks, support the development and the implementation of mitigation strategies and processes within the EMEA region.
Follow regulatory developments within the EMEA region and share knowledge of EU regulatory requirements for Medical Devices and Drugs which may impact the BD Business in EMEA
Provide other duties and assignments as required
About you
Preferably with scientific educational background.
Experience in the Regulatory Affairs, preferably in the Medical field with International experience. Drug experience would be a plus.
Applies knowledge and skills to a wide range of standard and non-standard situations. Works independently with minimal guidance. Usually determines own work priorities. Acts as a resource for colleagues with less experience
Organizational and planning skills, including action oriented, focused urgency, and driving for results
Ability to juggle multiple tasks and to prioritize and schedule work to meet business needs
Analytical problem solving
Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; and effective interactions with technical personnel (scientific and legal)
Ability to work in an international environment
Native level English proficiency, both written and verbal
Orientation for detail work product, with emphasis on accuracy and completeness
Promotes a collaborative environment and removes obstacles to teamwork across the organization
Computer literate
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
ESP BarcelonaWork 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.