GROW WITH US“In Tandem” means together, and we strive to embody that in every aspect of our business. Whether your 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 EVERYDAYAt 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™ TechnologyA DAY IN THE LIFE:Responsible for the independent 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. Prepares, reviews, and submits applications and other filings to various regulatory agencies. Represents the Regulatory Affairs department as a member of project teams, certain boards, and as part of other meetings as the need arises.YOU’RE AWESOME AT:
Provides regulatory affairs support for all aspects of product development and manufacturing.
Reviews and approves document change orders and determines regulatory strategies for each change.
Prepares regulatory submissions for new product clearances/approvals for domestic and international markets including PMAs, 510(k)s, dossiers, technical files, registrations, etc.
Independently interacts with various departments throughout the company to provide guidance for future regulatory submissions and to ensure compliance.
Responsible for global regulatory compliance activities such as manufacturing site registration, GMP/MDSAP audits, post-market vigilance reporting, product recalls, etc.
Ensures compliance with applicable domestic and international regulations related to Risk Management and Medical Device Reporting.
Assists with audits internal and external from various regulatory agencies.
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.
Bachelor’s degree in a science discipline preferred, or equivalent combination of education and applicable job experience.
2+ years of experience working in regulatory affairs and/or quality assurance in the medical device industry.
Demonstrated ability to: work independently, accurately, follow instructions and schedules, and handle multiple priorities.
Excellent technical writing, editing, and proofreading skills.
Skilled at analytical problem solving and communicating with diverse groups.
Works on multiple assignments in collaboration with various department system owners.
Demonstrated knowledge of and experience with the US and EU medical device regulations.
Skilled with MS Office applications, Adobe Acrobat, document control applications, and other computer based applications.
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 USTandem 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.REFERRALSWe love a good referral! If you know someone that would be a great fit for this position, please share!