Becton Dickinson

Sr. Regulatory Affairs Specialist

San Jose, , United States · Senior · Contract

Sponsorship not specifiedDetected 1577 days ago

Project ManagementFDA RegulatoryRegulatory Affairs

About the role

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.
We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Review/ Approve labels, labeling, and promotional materials for compliance with applicable regulations and policies.

Develop and execute international regulatory strategy for the successful registration of in vitro diagnostic (IVD) devices in markets outside of US and EU.
Negotiate and establish product submission priorities that are aligned with IVDR priorities and region/country needs.Understands and interprets EU and international in vitro diagnostic (IVD) device regulatory requirements.Generate, coordinate, and manage regulatory submission documents for new products, renewals, or changes to existing products; ensure compliance with global regulations and guidelines.
Job responsibilities:Develop and execute international regulatory strategy for the successful registration of in vitro diagnostic (IVD) devices in markets outside of US and EU.

Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.

Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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 o

This listing is sourced directly from Becton Dickinson's careers page and normalized into a canonical job model.