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Regulatory Affairs Expert at Tandem Diabetes Care - ApplyBlast

Regulatory Affairs Expert

Tandem Diabetes Care

5 months ago

3.1 on Glassdoor

Lausanne, Switzerland

Onsite

Full Time

Senior

0 applicants

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About this role

A Regulatory Affairs Expert develops and executes strategies to support product registrations, entity set-up, and ongoing compliance with country-specific requirements, ensuring adherence to applicable regulations and driving local regulatory intelligence activities.

Responsibilities

Defines and implements international regulatory strategies for product registrations and expansion
Executes new product submissions and post-approval change management activities
Ensures regulatory readiness for product launches in alignment with business timelines
Manages regulatory activities and ensures timely escalation of risks
Acts as primary RA contact with local authorities and regulatory partners

Skills

Qualifications

Bachelor's degree in Biomedical Engineering, Life Sciences, Regulatory AffairsCertification (RAC) by the Regulatory Affairs Professional Society

About Tandem Diabetes Care

tandemdiabetes.com

Headquarters

San Diego, California, United States

Company Size

1001-5000 employees

View Profile

Tandem Diabetes Care designs and manufactures insulin pumps, software and services for diabetes management. Its t:slim X2 pump and Tandem Mobi system run on Control-IQ+ technology, integrate with CGMs, and support remote software updates and data sharing; the company also provides infusion sets, training and 24/7 support, with products marketed globally.