Licensing & Registration Specialist I

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:

• Coordinates ongoing activities required for maintenance of, or application for, licenses and registrations with state and federal agencies, regulatory bodies, and applicable accrediting agencies, including the preparation, review, and submission of information packages.
• Tracks licensing and registration renewal requirements to ensure compliance and timely submissions.
• Compiles information required for licensing and registration activities, as necessary.
• Maintains records of submission packages and communications with external agencies.
• Monitors licensing communications and prepares responses as needed, and forwards critical or urgent matters to management in a timely manner.
• Conducts self-audits as required by accrediting agencies and regulatory bodies.
• Functions as subject matter expert for state licensing activities and point of contact on cross-functional teams for licensing collaborations.
• Prepares and submits external notifications for QMS, regulatory and business changes.
• Coordinates quality system activities, including but not limited to quality system registrations and change notifications to regulatory agencies such as the review and routing of proposals, purchasing orders, and invoice approvals.
• Corresponds with external agencies as needed.
• Collaborates with internal departments such as Legal, Managed Care, Finance and Regulatory on activities related to licensing and registration.
• Conducts monthly status meetings to ensure cross-functional licensing needs are met.
• Supports external audits pertaining to licensing and registration activities.
• Generates metrics related to licensing and registration for distribution to senior management.
• Continuously evaluates processes and methods and seeks to improve systems.
• Collaborates with team members to implement process improvements and efficiencies.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• General administrative and clerical duties to support Quality department.
• May be required to administer, facilitate and coordinate internal audit corrective action plans.
• May be required to participate in the internal audit program.
• Other responsibilities as assigned.

YOU’RE AWESOME AT:

1. Knowledge, skills & abilities:

• Knowledge of medical device regulations, concepts, and guidelines.
• Able to communicate effectively in verbal and written form.
• Able to review, trend, analyze and report data using quality databases and/or Excel.
• Ability to diagnose problems and identify and implement appropriate solutions.
• Able to react to changing situations in a timely, calm, and confident manner; able to work in dynamic, fast-paced work environment.
• Demonstrated organizational skills and attention to detail.

2. Minimum certifications/educational level:

• Bachelor’s degree or equivalent combination of education and applicable job experience.

3. Minimum experience:

• 2+ years related experience in medical device or related field.
• Demonstrated competence with QSR and ISO 13485 requirements.
• Experience in Quality, Regulatory, or Commercial Contracts (e.g., Managed Care or Reimbursements), or any combination preferred.

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