Compliance Officers

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.Tandem Diabetes Care is proud to manufacture and sell the t:slim X2 insulin pump with Control-IQ technology. 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. 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.Product Development and International Registration SupportSupport 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. 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.Regulatory IntelligenceSupport 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 ComplianceReviews 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., Supports the regulatory reviews and approval of document and engineering change orders. Completes and maintains training records relevant to specific job responsibilities.Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.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+ years of 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: 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.~ Ability to recognize and correct non-conformances from accepted and documented practices.~ Ability to dive into details, translate and statistically analyze data, and effectively report results through written and/or graphical formats.~ Skilled with MS Office applications as well as Adobe Acrobat.~ Experience with document management systems and electronic device submissions (eCopies).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.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 thorough screening process comprised of a drug test (excluding Marijuana) and background check, which includes a review of criminal history information, to ensure our team continues to be a safe and innovative environment for all.The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.If you are applying for this job and live in California, please read Tandem's CCPA Notice:#