Sr Director, Regulatory Affairs

GROW WITH US:

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take a “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. Tandem is always looking to add talent that can help us manage our interests globally.

STAY AWESOME:

Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with -IQ technology — an advanced predictive algorithm that automates insulin delivery.

But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with type 1 diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

A DAY IN THE LIFE:

The Senior Director, Regulatory Affairs is responsible for leading the development and execution of the company’s Regulatory strategies. Success will be demonstrated through a strong knowledge of FDA and international guidance and regulations. As a Senior Director, this role acts as a liaison with business leadership to ensure that new market regulatory strategies are defined and implemented. The role acts as a subject matter expert for regulatory processes for Tandem products requiring FDA and OUS agency approvals by ensuring that all necessary applications and submissions are filed accurately and timely. As an RA leader, this role drives the continuous assessment and improvement of key business and regulatory processes to ensure compliance with regulations set forth by the USFDA, International Regulatory Agencies, and in conformance with Good Manufacturing Practices, 21CFR Part 820, 21CFR Part 803, 21CFR Part 806, European MDD, MDR and ISO 13485. The Senior Director plays a key role in the Regulatory Affairs continuous improvement program, defining the program’s goals, developing systematic problem solving and management techniques, and facilitating team activities. Additionally, the role prepares the regulatory organization for the challenges that come with rapid global growth as Tandem becomes a world market leader in high quality, leading edge, diabetes care products.

Working as Sr Director, Regulatory Affairs, International, you will...

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