Sr. Regulatory Affairs Specialist II

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:

The Sr. Regulatory Affairs Specialist II 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 MDD, MDR and ISO 13485. Prior experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare is highly desired for this role. 

YOU’RE AWESOME AT:

• Provides regulatory strategy to meet requirements from product ideation to premarket submissions/registrations, product launch and post market compliance, working closely with healthcare regulatory bodies globally (including EU & UK).
• 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.
• Serves as a lead on product design/development and sustaining engineering project teams. Reviews and approves change orders as well as provides regulatory input to support closure (IMS updates, Procedural changes, etc.)
• Identify gaps in product development plans that may pose regulatory issues and come up with novel development strategies.
• Provides regulatory input on promotional and advertising activities.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• 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.

EXTRA AWESOME:

• Bachelor's degree in Science, Regulatory Affairs, Technology, Engineering, or Mathematics, or equivalent combination of education and applicable job experience.
• Regulatory Affairs Certificate, preferred.
• 7+ years of related experience in regulatory function in medical device or health IT industry.
• 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).
• 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 and EU/UK.
• Demonstrated experience communicating with regulator