31 ago
|
BD
|
San Agustín del Guadalix
31 ago
BD
San Agustín del Guadalix
Now
- Job ID
- R-551448
- Category
- Regulatory Affairs
- Location
- San Agustín del Guadalix, Spain
- Region
- EMEA
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.
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/general regulations or changes to the product(s).
Main responsibilities will include:
The main activities of this role includes but are not limited to:
- 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 loca
📌 Regulatory Affairs Specialist Specimen Management Emea (San Agustín del Guadalix)
🏢 BD
📍 San Agustín del Guadalix