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 attandemdiabetes.com.
A DAY IN THE LIFE:
The Sr. Regulatory Affairs Specialist I is responsible for implementing strategies for worldwide regulatory approval to introduce new products to market, maintaining existing products, providing advice on regulatory requirements, preparing worldwide submissions, and obtaining 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.
YOU’RE AWESOME AT:
Regulatory
- Implements 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.
- Evaluate proposed engineering, manufacturing, labeling and quality system changes and perform global regulatory impact assessment for regulatory filings and approvals.
- Follows Medical Device regulations, with a particular emphasis on Software enabled devices and provides direction to product teams in understanding the impact of such regulations on existing and new products and solutions.
- Identify gaps in product development plans that may pose regulatory issues and come up with novel development strategies.
- Ensuring data privacy and security plans are aligned with corporate quality system, regulatory requirements.
- Serves 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.).
- Reviews and analyzes project and customer requirements and assists project teams in tailoring and using regulatory procedures, methods, templates and tools.
- Reviews and Completes US and OUS submissions as directed; liaising with the health authorities as needed.
- May support clinical trial management including the planning and preparation of submissions for clinical studies, including review of Clinical Evaluation Reports.
Regulatory Compliance
- Supports Tandem in FDA and other regulatory inspections as needed.
- Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
- Supports regulatory compliance activities, including manufacturing site registration, regulatory authority audits, post-market vigilance reporting, product recalls, etc., as needed.
- Provides regulatory input to Complaint, FA, and CAPA investigations. Represents Regulatory Affairs in the CAPA review board.
- Reviews labeling for global regulatory compliance.
- Reviews Non-Conformance Reports, Supplier Non-Conformance Reports for regulatory compliance.
- Assists in conducting internal/external audits, as needed.
- Keeps informed of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.
- Completes and maintains training records relevant to specific job responsibilities.
EXTRA AWESOME:
- Bachelor’s degree in science, Regulatory Affairs, Technology, Engineering, or Mathematics, or equivalent combination of education and applicable job experience.
- Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations is desirable.
- 5+ years of related experience in regulatory function in medical device or health industry.
- Demonstrated experience in writing, and submission of regulatory filings 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).
- 3+ years’ experience with document management systems and electronic device submissions
- 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.
- Experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare a plus.
- Ability to translate and simplify technical content or regulations and communicate to stakeholders.
- Some 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.
- Previous participation in Global Regulatory Strategy in the product development and commercialization process.
- Ability to recognize and correct 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 $95,000 – $102,000 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 10 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!
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-DW1