Sr. Regulatory Affairs Specialist

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:

Responsible for the 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 including all programs related to FDA and QSR compliance. Coordinates the preparation, review and submission of information packages to regulatory agencies. Supports regulatory intelligence function for tracking updates to standards and regulations globally. Reviews medical device promotional materials for compliance to US and international regulations.

YOU'RE AWESOME AT:

Product Development and International Registration Support

• Support preparation and filing of international premarket submissions as needed, including technical file preparation.

• Preparation of US regulatory submissions for new product introductions and product modifications including 510(k)s.

• Works with Regulatory leadership to assist in evaluating classification of new products, reviewing the regulatory impact of revised product designs, and preparing the submission of applications for clearance of new or revised product designs. Draft letters to file as applicable.

• Collaborates and builds relationships with external partners, including Tandem's continuous glucose monitoring partners.

• Manages regulatory submission files, including required responses to regulatory agencies.

• Participates on product development core teams as the regulatory representative.

• Participates and coordinates in project meetings, as needed to support the Regulatory function.

• May support clinical trial management including the planning and preparation of submissions for clinical studies.

Regulatory Intelligence

• Support regulatory intelligence function for tracking updates to standards and regulations globally.

• Keep company informed of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.

• Interprets Medical Device regulations and provides direction to company 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.

Regulatory Compliance

• Reviews promotional and marketing materials for compliance with regulatory standards.

• Evaluate proposed engineering, manufacturing, labeling and quality system changes and perform global regulatory impact assessment for regulatory filings and approvals.

• Supports regulatory compliance activities, including manufacturing site registration, GMP audit, etc., as needed.

• Supports the regulatory reviews and approval of document and engineering change orders. Assists in hosting inspections as needed.

• Assists in conducting internal/external audits, as needed.

• Completes and maintains training records relevant to specific job responsibilities.

• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

EXTRA AWESOME:

• Bachelor's degree in a related technical field or equivalent education and applicable work experience.

• Regulatory Affairs Certificate, preferred.

• Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations is desirable.

• 5 plus years' Regulatory Affairs / Quality Assurance experience within an FDA regulated medical device industry.

• Demonstrated experience in writing, and submission of regulatory filings including experience authoring a range of global regulatory submissions, (e.g., CE Mark technical documentation, IDE applications, 510(k), etc.).

• Demonstrated experience of European medical device regulations, including regulation (EU) 2017/745.

• Demonstrated knowledge of medical device regulations in other international markets, including but not limited to Canada, UK, and Australia.

• Previous participation in creation of a Global Regulatory Strategy in the product development and commercialization process.

• Proficient knowledge of quality standards: ISO 13485, 21 CFR Part 820 and other appropriate industry standards.

• 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.

• Understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies globally.

• Familiarity of medical device quality systems (QSR) related to regulatory activities.

• Excellent technical writing, editing, and proofreading skills.

• Skilled at analytical problem solving and communicating with culturally diverse groups.

• 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.

• 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.

• Works on multiple assignments in collaboration with various department system owners.

• Communicates in a professional and collaborative manner and clarifies priorities when faced with competing deadlines.

• Skilled at promoting team cooperation and a commitment to team success.

• Offers suggestions to improve and/or streamline department procedures when issues are identified.

• Skilled with MS Office applications as well as Adobe Acrobat.

• Experience with document management systems and electronic device submissions (eCopies).

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 $90,000 - $108,000 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.

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

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-Hybrid #LI-DW1