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:

The Principal Regulatory Affairs Specialist is responsible for developing strategies for worldwide regulatory approval to introduce new products to market, maintaining existing products, providing advice on regulatory requirements, preparing worldwide submissions, and negotiating their approval with the agencies. As a subject matter expert, this role drives continuous 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 MDR and ISO 13485.

YOU’RE AWESOME AT:

• Provide strategic product direction to product teams and cross functional partners to advise on global medical device regulation. Interprets Medical Device regulations, with a particular emphasis on Digital Health, Software as a medical device (SaMD), Cybersecurity, AI/ML enabled devices and provide direction to product teams in understanding the impact of such regulations on existing and new Digital Health products and solutions.
• Identify gaps in product development plans that may pose regulatory issues and come up with novel development strategies.
• Evaluate proposed engineering, manufacturing, labeling and quality system changes and perform global regulatory impact assessment for regulatory filings and approvals.
• Ensuring data privacy and security plans are aligned with corporate quality system, regulatory requirements, and digital health regulatory models and initiatives.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Serves as a lead on product design/development and sustaining engineering project teams.
• Acts as Tandem representative in FDA and other regulatory inspections as needed.
• Reviews and Complete US and OUS submissions as directed; liaising with the health authorities as needed.
• Reviews and analyzes project and customer requirements and assists project teams in tailoring and using regulatory procedures, methods, templates and tools.

EXTRA AWESOME:

• Bachelor’s degree in Science, Regulatory Affairs, Technology, Engineering, or Mathematics, Pharmacy or equivalent combination of education and applicable job experience.
• 11 years of related experience with a Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years of experience in regulatory function in medical device or health IT industry.
• Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations is desirable.
• Demonstrated experience in leading, designing, writing, and submission of regulatory filings and correspondence and/or approvals, including experience authoring a range of global regulatory submissions, (e.g., 510(k), De Novo, CE Mark etc.) and preparing regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International registrations).
• Proficient knowledge of quality standards: ISO 9001, ISO 13485, ISO 14001, ISO 11137, 21CFR Part 820 and other appropriate industry standards.
• Strong knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
• Significant experience with products containing software, including knowledge of the software life cycle.
• Working knowledge of IEC 60601-series standards, specifically IEC 62304.
• Prior experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare.
• Ability to translate and simplify technical content or regulations and communicate to stakeholders.
• Strong understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies globally for diagnostic/digital health tool development and approval, with particular focus on US, Canada, and EU/UK.
• Anticipates business and regulatory issues; recommends product, process, or service improvements. Fosters ongoing awareness of developments in technology within the team.
• Demonstrated experience communicating with regulatory agencies including FDA, Health Canada, and EU regulatory agencies.
• Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the product development and commercialization process.
• Ability to recognize non-conformances from accepted and documented practices.
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
• Skilled at creating a cooperative team environment.
• Ability to dive into details, translate and statistically analyze data, and effectively report results through written and/or graphical formats.
• A positive approach to people and problem solutions along with a strong sense of discretion and the ability to maintain confidentiality.

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 $144,000 - $165,000 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. 

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.

APPLICATION DEADLINE: April 12, 2024

 #LI-Hybrid #LI-DW1