Sr. Regulatory Affairs 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:

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+ 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),