13 ago
|
Becton Dickinson
|
España
13 ago
Becton Dickinson
España
We are the people who give possibilities purpose BD is one of the largest integral 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 a
📌 Regulatory Affairs Specialist Specimen Management EMEA (España)
🏢 Becton Dickinson
📍 España