Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
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.
STAY AWESOME:
Tandem Diabetes Care is proud to manufacture and sell the t:slim X2 insulin pump with Control-IQ technology. We’re also 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. Since 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:
Responsible for the preparation and maintenance of domestic and international regulatory filings to meet corporate objectives and for the timely completion of other assigned activities related to regulatory support activities including all programs related to FDA and QSR compliance. Coordinates the preparation, review and submission of information packages to regulatory agencies. Supports regulatory intelligence function for tracking updates to standards and regulations globally. Reviews medical device promotional materials for compliance to US and international regulations.
YOU’RE AWESOME AT:
Product Development and International Registration Support
Regulatory Intelligence
Regulatory Compliance
EXTRA AWESOME:
WHAT’S IN IT FOR YOU?
In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit https://www.tandemdiabetes.com/careers.
BE YOU, WITH US!
Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.
COMPENSATION & BENEFITS:
The starting base pay range for this position is $90,000 - $108,000 annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus, equity, and a robust benefits package.
Tandem offers health care benefits such as medical, dental, vision, health savings accounts and flexible saving accounts. You’ll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (starting in year 1) and have access to a 401k plan with company match. Learn more about Tandem’s benefits here!
YOU SHOULD KNOW:
Potential new employees must successfully complete a drug screen (excludes marijuana) and background check which includes criminal search, education certification and employment verification prior to hire.
The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.
REFERRALS:
We love a good referral! If you know someone that would be a great fit for this position, please share!
If you are applying for this job and live in California, please read Tandem’s CCPA Notice: https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-for-job-applicants.
#LI-Hybrid #LI-DW1
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