Job Description Summary
As Regulatory Affairs Specialist, EMEA RA Support you will conduct regulatory activities ensuring regulatory compliance and supporting the Regulatory Affairs Support team (RAST). This role involves addressing internal and external customer needs, maintaining effective databases and communication systems with internal partners, providing regulatory expertise, and supporting the Regulatory Affairs Manager.Job Description
Main responsibilities will include:
- Conduct EMEA RA Support activities (including EMEA registration and in-country notification requests) effectively and compliantly.
- Handle EMEA Customer & Tender Queries and importation requests (excluding B2B).
- Obtain Certificates of Free Sale (CFS) within EMEA, including invoicing and consular services.
- Understand and follow local, regional, and corporate procedures applicable to role.
- Ensure RAST processes and procedures related to regulatory responsibilities are maintained as compliant, current, and efficient.
- Effectively navigate organizational dynamics and collaborate with various teams, including but not limited to EMEA RA, and EMEA commercial teams.
- Maintain existing internal databases and provide support in developing efficient documentation and communication systems.
- Provide support to regulatory audits as appropriate.
- Act as a key partner addressing BD internal needs of customer-facing teams and customer needs.
- Provide regulatory expertise and/or project management to support BD projects as required.
About you
- Bachelor’s degree or equivalent experience, preferably in scientific field.
- 2 years of regulatory affairs experience in regulated products, including Medical Devices and/or in vitro diagnostic medical devices.
- Proficiency in English.
- Ability to navigate a complex matrix organization
- Able to work effectively as part of a remote team.
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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.
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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 mindset.
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
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