Regulatory Affairs Specialist - Data & Analytics (New Markets)

Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Leverage software and/or data analytics expertise to develop streamlined regulatory pathways for complex and innovative data-driven products. Contribute to the development of the project plan and other deliverables. Represent Regulatory Affairs in the development of Product Plans, Specifications, Risk Management and other required documents. Participate in Design Reviews when appropriate. Create and revise procedures as needed. Review and approve change orders and evaluate for submission requirements. Participate as an auditor, independently if appropriately trained.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist - Data & Analytics (New Markets) in 6340 Sequence Dr, San Diego, CA 92121, USA is $83,000-$108,000 per year. This salary range can vary based on the specific duties and responsibilities of the role, the size of the organization, and the geographic location of the job.

Founded in 1999, Dexcom, Inc. is transforming diabetes care and management by providing superior continuous glucose monitoring (CGM) technology to help patients and healthcare professionals better manage diabetes.