Find Jobs

Find Jobs Near You – Available Work in Your Location

Skip to job details

Apply for this opportunity

To apply for this job, you'll continue to an external website or email application.

Apply Offsite

TalentBurst, Inc

Regulatory Affairs Associate

Pay: Not specified

Posted: 8 weeks ago

Location: Los Angeles, CA (Onsite)

Last Updated: 3 weeks ago

Hours: Full-Time

Expires: 9/13/2026

Career Insights for Regulatory Affairs Specialist

See where this job fits in the broader career landscape. Knowing your career path helps you see what's possible from here.

Scorecard

Based on California data

Review key factors to help you decide if this role fits your goals. How is this calculated?

Were these scores useful?

What they do

A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.

$105,184 / year median in California

+1% projected growth

Explore Career

Job Description

Title:

Regulatory Affairs Associate

Location:

Sylmar

CA 91342

Duration:

Months Contract Shift:

08:00 AM - 05:00

PM Description:

This role is based in Sylmar, CA and requires employees to work on-site. Responsible for filing necessary regulatory applications and supporting interactions with U.S. and international regulatory authorities for products requiring governmental approval. Authoring and submitting

U.S. PMA

supplements (30-day Notices, Real-Time Reviews, 180-Day Supplements, Annual Reports), as well as supporting EU MDR Technical Documentation updates, change assessments, and Notified Body submissions. Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing and design changes for Class III implantable medical devices, including assessment of regulatory impact under both FDA and EU MDR requirements. Requires a bachelor's degree in a scientific or related discipline and at least 1 years of direct regulatory experience in the medical device field. Recent experience with Class III implantable medical devices preferred. Exposure to authoring and/or supporting PMA supplements and familiarity with EU MDR (2017/745) requirements are desirable. Working knowledge of FDA PMA guidance documents, 21 CFR regulations, and EU regulatory frameworks. Relies on experience and judgment to plan and accomplish assigned goals. Performs a variety of tasks with guidance as needed. Demonstrates accountability for deliverables and ability to follow through on submissions and regulatory activities. A moderate degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department. #TB_ PH #ZRHC Why TalentBurst? At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth. Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships. We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options. TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.