Senior Regulatory Affairs Specialist I (TAN-KL)

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Always be on the lookout for job scams! Learn more about identity theft Opens in new window Help information , opens a new window. Info First Job Previous Job 793 of 6,449 Next Job Last Job Share More Like This Salary Confidential Senior Regulatory Affairs Specialist I (TAN-KL) Tandem Diabetes Care, Inc

Occupation:

Regulatory Affairs Specialists

Location:

San Diego, CA - 92130

Job Type:

Regular, Full Time (30 Hours or More), Permanent Employment, Day Shift

Posted:

04/30/2026 Positions available: 1

Source:

CalJOBS

Web Site:

CalJOBS Onsite /

Remote:

Not Specified

Updated:

05/01/2026

Expires:

06/02/2026

Agency Job ID:

TAN-KL Job #: 19850883 Job Requirements and Properties Help for Job Requirements and Properties. Opens a new window. Work Onsite Full Time Education Master's Degree Experience 36 Month(s) Schedule Full Time Job Type Regular Duration Permanent Employment Hours 40 Hours Per Week Shift Day Shift Job Description Help for Job Description. Opens a new window. Tandem Diabetes Care, Inc. has the following position available in

San Diego, CA:

Senior Regulatory Affairs Specialist I (TAN-KL): Support preparation and filing of international premarket submissions as needed, including technical file preparation. Prepare U.S. regulatory submissions for new product introductions and product modifications including 510(k)s, De Novos, Medical Device License (MDL) applications. Work with Regulatory leadership to assist in evaluating classification of new products, review the regulatory impact of revised product designs, and prepare the submission of applications for clearance of new or revised product designs. Evaluate proposed engineering, manufacturing, labeling and quality system changes and perform global regulatory impact assessment for regulatory filings and approvals. Support regulatory compliance activities, including manufacturing site registration, GUDID, GS1, establishment registrations, GMP audit, etc., as needed. Draft letters to file for US 510(k) as applicable. Support regulatory reviews and approval of document and engineering change orders. Collaborate and build relationships with external partners, including Tandem's continuous glucose monitoring partners. Manage regulatory submission files, including required responses to regulatory agencies. Participate in product development core teams as the regulatory representative. Participate and coordinate in project meetings, as needed to support the regulatory function. Support clinical trial management including the planning and preparation of submissions for clinical studies. 100% Telecommuting permitted from anywhere in the U.S.

Minimum Requirements:

Master's degree or foreign degree equivalent in Biotechnology, Biomedical Engineering, Biology, or related field, plus three (3) years of experience in job offered, Regulatory Affairs / Quality Assurance experience within an FDA regulated medical device industry, or related occupation. Submit resume to

Attn:

Kenneth Truong, careers@tandemdiabetes.com. Must reference job title and job code: TAN-KL.

Annual salary range:

$112,200.00 - $122,200.00. Tandem Diabetes Care, Inc Is a Private Sector employer with 3 locations

Company Profile:

(Confidential) 1,000-4,999 employees Connect with Tandem Diabetes Care, Inc Location/Work Site Information Help for Location/Work Site Information. Opens a new window. Cost of Living Calculator Help for Cost of Living Calculator. Opens a new window. Compensation and Benefits Help for Compensation and Benefits. Opens a new window. Job Type and Required Hours Help for Job Type and Required Hours. Opens a new window. Work Experience Help for Work Experience. Opens a new window. Education and Training Help for Education and Training. Opens a new window. Skills Required Help for Skills Required. Opens a new window. Occupation Information for Regulatory Affairs Specialists Help for Occupation Information for Regulatory Affairs Specialists. Opens a new window. Other Jobs and Employers Career Ladder Help for Career Ladder. Opens a new window. Personal Requirements Help for Personal Requirements. Opens a new window. Nature of the Work Help for Nature of the Work. Opens a new window. Work Values and Activities Help for Work Values and Activities. Opens a new window. Change Job Search Criteria Print Job Order Opens in new window [ Do you have a comment or concern about this job posting? ] About Sign In / Register Home Site Map Site Search Explore CalJOBS Settings Accessibility Statement Preferred Settings Page Preferences Languages Services For Individuals For Employers Labor Market Mobile App Legal Privacy Statement Terms of Use Disclaimer Equal Employment Opportunity Resources Protect Yourself Assistance CalJOBS Contact Us Statewide Sacramento, CA 94280 Copyright © 1998-2026 Geographic Solutions, Inc. All Rights Reserved. Virtual OneStop® - VOS Sapphire AI v24