GROW WITH US:

“In Tandem” means together, and we strive to embody that in every aspect of our business. Whether you’re office-based or fully remote, Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and the healthcare providers supporting them through a positively different experience.

INNOVATE EVERYDAY

At Tandem, we strive to put our values into action. Our “Team Up”, “No shortcuts” approach has propelled us to be an industry leader and make significant strides in the diabetes technology space. We are proud to be the makers of the only color, touch-screen insulin pump that is capable of remote feature updates and compatibility with continuous glucose monitoring. Watch our latest video to see our product features and capabilities here: t:slim X2™ Insulin Pump with Control-IQ™ Technology

A DAY IN THE LIFE:

This role can be Remote, however we will need for the candidate in this role to come into the office on occasion for audit support, so we are currently open to someone within a commutable distance and time zone to our San Diego office.

Supporting Regulatory post-market sustaining and operations management for medical device hardware, software, and accessories. Our Regulatory Affairs Specialists are responsible for ensuring medical device compliance with all global applicable regulations for regulatory projects to meet corporate objectives. Fostering collaboration with key functional groups in Quality, Engineering, Marketing, Product Development, Manufacturing and Clinical Operations to educate and gain alignment of global regulatory strategies. Preparing, reviewing, and submitting applications and other filings to various regulatory agencies as well as representing the Regulatory Affairs department as a member of project teams, certain boards, and as part of other meetings as the need arises.

• Provides regulatory affairs support for all aspects of product development and manufacturing.
• Reviews, approves, and documents changes to devices and determines regulatory strategies for each change.
• Prepares letters-to-file or change notices as needed.
• Responsible for regulatory compliance activities such as unique device identifier (UDI) implementation, quality system changes, manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc.
• Ensures compliance with applicable domestic and international regulations related to Risk Management and Medical Device Reporting.
• Independently interacts with various departments throughout the company with future regulatory submissions in mind and to ensure compliance.
• Assists in preparing regulatory submissions for new product clearances/approvals including 510(k)s, dossiers, technical files, etc.
• Assists in hosting inspections from various regulatory agencies.
• Takes an active role in both internal/external audits.
• Keeps informed of current regulations, standards, policies, and guidance that impact the company’s regulatory methods.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

YOU’RE AWESOME AT:

• Bachelor's degree in Science, Regulatory Affairs, Technology, Engineering, or Mathematics, or equivalent combination of education and applicable job experience.
• Master’s degree preferred.
• Regulatory Affairs Certificate, preferred.
• 2-4+ years of direct experience in the medical device industry, medical device manufacturing, medical device product or mechanical engineering, quality assurance or quality engineering experience.
• Demonstrated ability to: work independently, quickly, accurately, follow instructions and schedules, and handle multiple priorities.
• Excellent technical writing, editing, and proofreading skills.
• Able to apply basic scientific principles to analyze and develop persuasive speech and writing.
• Skilled at analytical problem solving and communicating with diverse groups.
• Works on multiple assignments in collaboration with various department system owners.
• Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
• Skilled at promoting team cooperation and a commitment to team success.
• Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.
• Skilled with MS Office applications, Adobe Acrobat, electronic document management systems, and other computer-based applications.
• Demonstrated knowledge of US FDA, EU MDR and Canadian regulations and guidance’s

EXTRA AWESOME:

• Experience supporting manufacturing operations
• RAC or CQA certifications a plus, but not required
• Experience with USA Class II and EU Class IIa/IIb

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.

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-Remote #LI-Hybrid #LI-DW1