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 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 Sr. 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 MDD, MDR and ISO 13485. Please note; The ideal candidate for this role will have prior experience supporting class III devices per Regulation (EU) 2017/745 requirements. Sr RASs at Tandem are also responsible for: Serves as regulatory lead on sustaining engineering project teams providing the regulatory assessment of impact of design and manufacturing changes on medical devices in markets such as the EU, UK, Australia, Israel, Saudi Reviews medical device promotional materials for compliance to US and international regulations. Serves as a lead on product design/development project teams. Reviews and completes US and OUS submissions as directed; liaising with the health authorities as needed. Acts as Tandem representative in regulatory inspections as needed. Provides regulatory strategy, guidance on risk assessment and required corrective action to meet requirements from product ideation to premarket submissions/registrations, product launch and post market compliance, working closely with healthcare regulatory bodies globally. Interprets Medical Device regulations, with a particular emphasis on Digital Health, Software as a medical device (SaMD), and provides 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. Reviews and analyzes project and customer requirements and assist project teams in tailoring and using regulatory procedures, methods, templates and tools. Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements. WHAT YOU'LL NEED: Bachelor's degree in Science, Regulatory Affairs, Technology, Engineering, or Mathematics, or equivalent combination of education and applicable job experience. Regulatory Affairs Certificate, preferred. Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations is desirable. 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 13485, 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 medical device software (MDSW) and active medical devices. 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 EU/UK. 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. WHEN & WHERE YOU'LL WORK: Hybrid: This role will be a mix of in-office work at our corporate headquarters in Del Mar, CA and remote work. This position is expected to be in office 2-3 days per week but may vary depending on business demands. COMPENSATION & BENEFITS: The starting base pay range for this position is $120,000 - $135,000 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 and a robust benefits package. Tandem offers health care benefits such as medical, dental, vision available your first day, as well as 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 (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan. Learn more about Tandem's benefits here! 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. 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. 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. REFERRALS: We love a good referral! If you know someone who would be a great fit for this position, please share! 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-Hybrid #LI-DW1 Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company's pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California.