Regulatory Affairs Intern

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 the “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 Tandem Mobi system and t:slim X2 insulin pump with Control -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 https://www.tandemdiabetes.com/

A DAY IN THE LIFE:

Provides regulatory documentation and data management support to Regulatory Specialists in updating and maintaining compliance with the European Database on Medical Devices (EUDAMED).

Regulatory Affairs Intern’s at Tandem are also responsible for:

• Assists in the preparation, validation, and submission of regulatory data into EUDAMED
• Ensures accurate and up-to-date documentation of device registrations, economic operators, and certificates
• Supports the review and verification of Unique Device Identification (UDI) requirements in compliance with the EU Medical Device Regulation (MDR 2017/745)
• Coordinates with internal teams to gather necessary regulatory information
• Monitors updates to EU MDR regulations and their impact on EUDAMED compliance
• Identifies and resolves data inconsistencies or gaps in regulatory needs

WHAT YOU’LL NEED:

Knowledge, skills & abilities:

• Prior experience working with MS Office products including Outlook, Word, Excel & PowerPoint
• Strong computer skills
• Excellent organizational skills
• Strong written & verbal communication skills
• Ability to work independently on assigned tasks
• Able to work effectively in a team environment

Minimum certifications/educational level:

• Currently pursuing or recently completed a degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or related field

Minimum experience:

• A working knowledge of Microsoft Teams or experience with a remote learning or work environment
• Prior knowledge of insulin pumps, infusion sets, or digital health a plus
• Completion of a regulatory affairs, medical device, or quality assurance course preferred

PHYSICAL REQUIREMENTS:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment.  Employees must occasionally lift and/or move up to 45 pounds.

WHY YOU’LL LOVE WORKING HERE:

At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie.  This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.

BE YOU, WITH US!

We embrace the value that every single one of us brings 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. 

Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation.  We are an inclusive organization, and we welcome applications from a wide range of candidates.  Selection for roles will be based on individual merit alone. 

COMPENSATION & BENEFITS:

The starting base pay range for this position is $20.00 - $28.00 per hour. 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.

Tandem offers an environment where you are encouraged to be imaginative and intuitive, with the ability to envision what’s possible for people living with diabetes.  We aim to uplift, encourage, and support everyone in the diabetes community.  Tandem put’s people first and firmly believe that we can make a positively different impact by bringing the right people to improve ideas, solutions, and our company!

YOU SHOULD KNOW: 

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information.

Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.

REFERRALS:

We love a good referral! If you know someone who would be a great fit for this position, please share!

SPONSORSHIP:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

APPLICATION DEADLINE:

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.

#LI-Onsite   #LI-CM2

Salary : $20 - $28