Regulatory Affairs Specialist Specimen Management Emea (España)

Regulatory Affairs Specialist Specimen Management Emea (España)

05 ago
|
Becton Dickinson
|
España

05 ago

Becton Dickinson

España

We are the people who give possibilities purpose 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.
Job Description 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.
About the role Being a key strategic partner for the EMEA BD Business by (i) supporting the implementation of registration/regulatory strategies for the BD SM portfolio, 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). This role may also involve reviewing and approving promotional material, managing regulatory and product related documentation, providing local regulatory support, and participating in projects. The Regulatory Specialist works closely with cross-functional teams to support business initiatives and offer subject matter expertise on EMEA legislation and standards.
Main responsibilities 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.
Execute on 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
Address product-specific regulatory queries from local teams to support market access and compliance
Provide other duties and assignments as required.
Salary range for this role: EUR 35,000 - EUR 40,000
Why Join Us? 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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit Dickinson, and Company is an Equal Opportunity Employer.
We evaluate applicants without regard to 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,



and other legally protected characteristics.
Required Skills Optional Skills Primary Work Location ESP San Agustin del Guadalix
Additional Locations Work Shift At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You". Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information €32,700.00 - €52,350.00 EUR Annual
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one integral mission to make a difference in human health.
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📌 Regulatory Affairs Specialist Specimen Management Emea (España)
🏢 Becton Dickinson
📍 España

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